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8 HOURS WEBINAR-FDA’S REGULATION OF OTC DRUG PRODUCTS WHAT IT IS, HOW TO ANALYZE
IT, MAKE IT WORK FOR YOU

WEBINAR

8 Hours Webinar-FDA’s Regulation of OTC Drug Products What It Is, How to Analyze
It, Make It Work for You

COURSE DATE & TIME

Oct 20, 2022 - 13:00:00 EST

COURSE DURATION

2 Days

COURSE DURATION

80 Minutes


$999$899

Buy Now
 * Overview

DESCRIPTION



This session is scheduled for the 20th and 21st of Oct 2022. The webinar will
start from 1.00 pm ET to 5.00 pm ET on both days.

 

FDA Regulations of OTC drugs Course Overview
This 2 day course online is intended to provide participants with the knowledge
and skills needed to develop and produce an OTC Drug Product for marketing and
sale in the U.S. Attendees will gain an understanding of the various available
options for producing and selling an OTC Drug Product, will leave the workshop
with an understanding of the U.S. Food and Drug Administration’s (“FDA”)
regulation of such products, and will be provided with strategic recommendations
for mitigating the risk of enforcement action in the future.  

Have a Headache? Back from lunch and now experiencing mild occasional Heart
Burn? Suffer from Allergies? Been stuck in bed with a Cough, Sore Throat, Nasal
Congestion and a Fever you just can’t shake? Pitched the tent in Poison Ivy on
last weekend’s family camping trip by mistake? Use Deodorant?  

Over-the-Counter Drug Products or “OTC Drugs” include many of the well-known
products that we use to treat or control the symptoms of occasional and moderate
health conditions. Available without a prescription and for purchase directly
off-the-shelf, OTC drug products currently represent nearly 60% of all drug
products sold in the United States.

Anyone who has ever suffered from these or similar occasional symptoms and
conditions has likely relied upon an Over-the-Counter Drug Product or “OTC Drug”
to feel better. Go into any CVS Retail Pharmacy, Wal-Mart, Meijer Grocery Story,
Rite Aid Retail Pharmacy or Target in the United States; you are guaranteed to
find store shelves lined with hundreds or even thousands of different OTC Drug
products.  Some of the most recognized OTC drug products include ibuprofen
tablets, anti-itch creams, nasal decongestant sprays, cough syrups, antacids,
allergy medicines and topical pain relievers. Available without a prescription
and bought right off the store shelf, OTC drugs are safe and effective when
properly labeled and used as intended.

The U.S. Food and Drug Administration’s (“FDA”) is responsible for the
regulation and oversight of the U.S. OTC drug market. Congress has granted FDA
regulatory authority over the formulation, manufacturing, labeling, marketing
and promotion; and import / export of OCT drug products into the U.S.  Under
this current regulatory regime, there are 3 pathways that a company may follow
to enter the OTC drug market including (a) following an appropriate Drug
Monograph; (b) with an Agency approved New Drug Application (“NDA”); or (c) via
the currently popular Rx-to-OTC Switch Process. 

Market studies suggest that there are currently over 300,000 OTC Drugs being
marketed and sold in the U.S. today and that number is growing daily. This
amounts to almost 60% of the total U.S. drug market (by purchases) and this
number is expected to grow in the future. Based on these predictions alone, this
is a profitable market and growth potential that drug and health product
companies cannot afford to ignore.

If you can cook and follow a recipe; then you can make an OTC Drug Product with
access to the necessary resources and an appropriate facility. 

 

Training Agenda Day 1

 * Overview of Drug Regulation in the United States
 * Structure of FDA: Specifics of CDER
 * Intro to the FDCA, Regulations, and Guidance Documents 
 * OTC drugs v. Rx Drugs
 * History of Regulation of OTC Drugs in the US
 * OTC Drug Review Process
 * OTC Drug Monographs
 * Final OTC monograph establishes the acceptable:
 * Marketing the OTC drug product when the Monograph is not final.

 

Training Agenda Day 2

 * 2020 Changes to the OTC Monograph System Under the CARES Act
 * OMUFA and the Coronavirus Aid, Relief, and Economic Security (CARES) Act
 * What to do about the Changes? 
 * Status of specific OTC Monographs, their included Regulatory Requirements and
   Strategies for Commercialization
 * OTC Drug Ingredients
 * Marketing a drug product that deviates from a final monograph
 * OTC Drug Labels, Labeling, Marketing and Advertising Issues
 * Definitions of the terms “label” and “labeling”
 * Labeling includes the Immediate Container, Outer Packaging, Package Insert,
   Client Information Sheet, Shipping Label
 * Elements of an OTC Drug compliant labelPromotional MaterialsStrategies for
   Regulatory Compliance
 * FDA Enforcement Actions
 * Park Doctrine – Corporate Official Liability under FDCA
 * Overlapping Agency Jurisdiction – FDA, DOJ, FTC, USDA, and State Agencies

 

Learning Objectives:
Participants who attend this course will:

 * Gain a comprehensive understanding of how OTC Drug Products are regulated in
   the U.S. 
 * Learn to distinguish between a potential Rx pharmaceutical product and an OTC
   drug.
 * Recognize the difference between the various pathways for commercializing an
   OTC Drug Product.
 * Understand how to identify and successfully navigate an OTC Drug Monograph.
 * Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph
   is appropriate.
 * Understand how to determine whether an Ingredient is considered Safe or
   GRAS/E for use in an OTC Drug and understand the difference between Category
   I, II and II Ingredient designations.
 * Identify the required elements of a compliant OTC Drug Label.
 * Take away strategies for marketing and promoting OTC drug products, and for
   mitigating potential enforcement risks.
 * Possess a working knowledge of the Rx-to-OTC Switch Process.
 * Review and evaluate several of FDA’s current OTC Monographs.


 

Who will Benefit

This includes individuals responsible for overseeing regulatory affairs,
developing strategies for obtaining drug product approvals and those tasked with
ensuring corporate compliance. Among others, this includes:

 * Senior quality managers
 * Quality professionals
 * Regulatory professionals
 * Compliance professionals
 * Production supervisors
 * Manufacturing engineers
 * Production engineers
 * Design engineers
 * Labelers and Private Labelers
 * Contract Manufacturers
 * Importers and Custom Agents
 * U.S. Agents of Foreign Corporations
 * Process owners
 * Quality engineers
 * Quality auditors
 * Document control specialists
 * Record retention specialists
 * Medical affairs
 * Legal Professionals
 * Financial Advisors and Institutional Investors
 * Consultants, Inspectors and cGMP Experts



PLEASE CHECK THE DESCRIPTION




BOOKING

Attend Live Webinar :

 * Single Attendee
   
   $899

 * Group of 3 to 5
   
   $1299

 * Group of 6 to 10
   
   $1499
 * 
 * 

 * Single Attendee + Video session
   
   $1297

 * Single Attendee + CD/USB
   
   $1497

 * Group of 3 to 5 + CD/USB
   
   $1797

 * Group of 6 to 10 + CD/USB
   
   $1997
   

Recorded Version :

 * 
 * 
 * 

 * CD-USB
   
   $1298

 * Video session
   
   $998
 * 
 * 
 * 
 * 
   
 * Total Price 0
 * Email Address
   Phone
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   See our Refund Policies
   
   
   Book Now
   


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