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OnlineComplianceExperts
Knowledge. Creativity. Performance

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SPEAKER PROFILE


Robert J. Russell
President & CEO,



Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior
industry experience in international regulatory management and compliance,
global business development and global supply chain management. Mr. Russell
formerly held senior leadership positions, in these functional areas, at Dow
Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority's requirements and
regulatory processes across Life Science products. For the past 18 years, Bob
has been President & CEO of RJR Consulting, Inc. The company assists the
pharmaceutical, medical device and biotech industries in understanding
Regulations affecting compliance and in conducting product registrations with
their clients in more than 95 countries. He holds a BS / MS in Chemistry."

Upcoming Webinars Recorded Webinars
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Friday

10:00 AM PDT | 01:00 PM EDT


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Robert J. Russell | Duration:4 Hours | Price: 445,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Robert J. Russell | Duration:3 Hours | Price: 299,00 € | View Details
 * Monday

10:00 AM PDT | 01:00 PM EDT


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Robert J. Russell | Duration:6 Hours | Price: 545,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Tuesday

08:00 AM PDT | 11:00 AM EDT


6-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Robert J. Russell | Duration:6 Hours | Price: 545,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Friday

08:00 AM PDT | 11:00 AM EDT


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Robert J. Russell | Duration:4 Hours | Price: 445,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Robert J. Russell | Duration:3 Hours | Price: 299,00 € | View Details
 * Tuesday

10:00 AM PDT | 01:00 PM EDT


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Friday

10:00 AM PDT | 01:00 PM EDT


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Friday

08:00 AM PDT | 11:00 AM EDT


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Robert J. Russell | Duration:6 Hours | Price: 545,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Wednesday

10:00 AM PDT | 01:00 PM EDT


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Robert J. Russell | Duration:3 Hours | Price: 299,00 € | View Details
 * Monday

10:00 AM PDT | 01:00 PM EDT


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details
 * Thursday

10:00 AM PDT | 01:00 PM EDT


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Robert J. Russell | Duration:90 Minutes | Price: 149,00 € | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL AND
MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


4-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 495,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 495,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL AND
MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 495,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour seminar covers the details of the Regulatory Requirements for a wide
range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical
Devices, and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 349,00 €
| View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan. The course will cover topics relating to
pre-clinical and clinical requirements, as well as, addressing the structure of
the regulatory agencies in Japan. Content will also include descriptions of the
methods by which regulators in the corresponding agencies process filings and
registrations and what is expected in the authorization and dossier maintenance
of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


US MARKET ACCESS & REIMBURSEMENT; MEDICAL DEVICES

This targeted 60-minute U.S. Reimbursement training/webinar will help you
understand and navigate the complex U.S. system for understanding product
reimbursement status and potential for your Medical Device.

Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: 199,00
€ | View Details


US, EU, JAPAN GMP REQUIREMENTS

This ICH GMP 90-minute webinar will provide your company the opportunity for
comprehensive understanding of ICH Drug / Biologic GMP and the nuances and
differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


CHINA REGULATORY COMPLIANCE FOR LIFE SCIENCES

China's Life Sciences Compliance webinar will discuss the regulatory structure
and requirements for compliance against China's NMPA regulations for
Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 495,00 €
| View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 349,00 €
| View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 349,00 €
| View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 349,00 €
| View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 199,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 495,00 €
| View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 595,00 €
| View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


4-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 845,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 845,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL AND
MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 845,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour seminar covers the details of the Regulatory Requirements for a wide
range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical
Devices, and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 549,00 €
| View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan. The course will cover topics relating to
pre-clinical and clinical requirements, as well as, addressing the structure of
the regulatory agencies in Japan. Content will also include descriptions of the
methods by which regulators in the corresponding agencies process filings and
registrations and what is expected in the authorization and dossier maintenance
of licensed products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


US MARKET ACCESS & REIMBURSEMENT; MEDICAL DEVICES

This targeted 60-minute U.S. Reimbursement training/webinar will help you
understand and navigate the complex U.S. system for understanding product
reimbursement status and potential for your Medical Device.

Speaker: Robert J. Russell | View Anytime | Duration: 60 Minutes | Price: 399,00
€ | View Details


US, EU, JAPAN GMP REQUIREMENTS

This ICH GMP 90-minute webinar will provide your company the opportunity for
comprehensive understanding of ICH Drug / Biologic GMP and the nuances and
differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


CHINA REGULATORY COMPLIANCE FOR LIFE SCIENCES

China's Life Sciences Compliance webinar will discuss the regulatory structure
and requirements for compliance against China's NMPA regulations for
Pharmaceuticals, Medical Devices, Biologics and Combination Products.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 845,00 €
| View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 549,00 €
| View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 549,00 €
| View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE PROCESSES FOR LIFE
SCIENCES

This course specifically focuses on the overall regulatory compliance
requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and
Combination Products in Japan.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


LATIN AMERICA REGULATORY COMPLIANCE: CURRENT CHALLENGES IN ARGENTINA, BRAZIL,
AND MEXICO

The Latin America Regulatory compliance requirement training/webinar will cover
topics across the full Life-Cycle of Company & Product licensing in the key
markets of Latin America.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


3-HOUR VIRTUAL SEMINAR ON JAPAN - REGULATORY FILING REQUIREMENTS AND COMPLIANCE
PROCESSES FOR LIFE SCIENCES

This 3-Hour webinar covers the details of the Regulatory Requirements for a
wide-range of Life Science products in Japan: Pharmaceuticals, Biologics,
Medical Devices and Combination Products. The syllabus also covers the change in
Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the
Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to
GMP requirements.

Speaker: Robert J. Russell | View Anytime | Duration: 3 Hours | Price: 549,00 €
| View Details


EU MEDICAL DEVICE REGULATION (MDR) - UPDATED CE MARKING PROCESS & ISO 13485:2016
EXPECTATIONS

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the
recently developed regulation and its impact on the future compliance and
registration of medical devices in the EU.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


DRUG MASTER FILES: UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING
RESPONSIBILITIES

This combined Quality Agreement and DMF (Drug Master Files) training will
discuss the advantages for suppliers and drug product manufacturers developing
these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 90 Minutes | Price: 399,00
€ | View Details


6-HOUR VIRTUAL SEMINAR ON THE USE OF DRUG MASTER FILES & QUALITY AGREEMENTS:
UNDERSTANDING AND MEETING YOUR REGULATORY AND PROCESSING RESPONSIBILITIES

This combined DMF (Drug Master Files) and Quality Agreement training will
discuss the advantages for suppliers and drug product manufacturers in
developing these arrangements together.

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


4-HOUR VIRTUAL SEMINAR ON MEDICAL DEVICE SINGLE AUDIT PROGRAM [MDSAP]
IMPLEMENTATION & PARTICIPATING COUNTRY REGULATORY PROCESSES: U.S., CANADA,
BRAZIL, AUSTRALIA, AND JAPAN

Global Medical Device Regulations continue to evolve, as devices become more
diverse and sophisticated.

Speaker: Robert J. Russell | View Anytime | Duration: 4 Hours | Price: 845,00 €
| View Details


6-HOUR VIRTUAL SEMINAR ON THE EU CLINICAL TRIAL REGULATION - EU FILINGS &
REGISTRATIONS

This course covers the requirements for conducting Clinical Studies across the
EU via the requirements of the EU Clinical Trial Regulation (for Drugs &
Biologics).

Speaker: Robert J. Russell | View Anytime | Duration: 6 Hours | Price: 945,00 €
| View Details


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