WEBINARS

 

Drug Marketing Regulatory Compliance Training - Live Webinars, Recordings & CDs

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

7 / Dec / 2021 - Tuesday

* Per Attendee $229

 

How to Survive a DEA Inspection Series - For Manufacturers of Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 705164

This training covers DEA record-keeping and security topics that a DEA registrant must comply with when handling controlled substances. The focus is elements of what occurs during that unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   120 Min

Product Id: 702317

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

Recording Available

* Per Attendee $349

 

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

webinar-speaker   Travis Austin MacKay

webinar-time   90 Min

Product Id: 702154

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

Recording Available

* Per Attendee $279

 

Japan: Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702979

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Recording Available

* Per Attendee $299

 

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

webinar-speaker   Vanessa Lopez

webinar-time   90 Min

Product Id: 704758

This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.

Recording Available

* Per Attendee $299

 

OTC Drug Regulations

webinar-speaker   Loren Gelber

webinar-time   60 Min

Product Id: 705446

This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.

Recording Available

* Per Attendee $279

 

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

webinar-speaker   Norma Skolnik

webinar-time   60 Min

Product Id: 704371

In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.

Recording Available

* Per Attendee $249

 

FDA Regulations and New Legislation for Marketing Cosmetics in the U.S

webinar-speaker   Norma Skolnik

webinar-time   60 Min

Product Id: 704317

The webinar training will cover FDA regulations for marketing cosmetics and help attendees learn about new proposed legislation which will place new requirements on cosmetic product marketing in the U.S.

Recording Available

* Per Attendee $299

 

Nutrition and Health Claims Regulation (NHCR) in the European Union

webinar-speaker   Vicente Rodriguez

webinar-time   60 Min

Product Id: 705492

This webinar on Nutrition and Health claims (NHCR) will provide guidance to any food business operator intending to present food products as having nutritional or health benefits should be aware of the legal possibilities and limitations that the EU system offers.

Recording Available

 

Commercial and HTA Policy in the UK

webinar-speaker   Leela Barham

webinar-time   90 Min

Product Id: 705431

This webinar will provide an understanding of the key European market’s approach to pricing including the details of Pharmaceutical Price Regulation Scheme (PPRS). It will further discuss the key issues shaping the future of HTA policy in the UK.

Recording Available

 

Drug Pharmacy Compounding

webinar-speaker   Rachelle D Souza

webinar-time   60 Min

Product Id: 704907

This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.

Recording Available

* Per Attendee $249

 

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

webinar-speaker   Rossano V Gerald

webinar-time   60 Min

Product Id: 705186

When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.

Recording Available

 

How to Survive a DEA Inspection Series: "Understanding a DEA Computation Chart for Manufacturers or FIND=FINE"

webinar-speaker   Carlos M Aquino

webinar-time   60 Min

Product Id: 705163

The presentation is tailored for those corporate leaders and employees of DEA registered manufacturers responsible for handling Schedules I through V controlled substances and List I regulated chemical products. This training will cover several recommendations to improve your methods of record-keeping required of DEA registrants.

Recording Available

 

Moving FDA Boundaries for Direct-to-Consumer Advertising

webinar-speaker   Casper Uldriks

webinar-time   90 Min

Product Id: 705033

FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.

Recording Available

* Per Attendee $279

 

Regulation of Natural Health Products in Canada

webinar-speaker   James Russell

webinar-time   90 Min

Product Id: 704044

This training program will discuss regulations that impact Natural Health Products in Canada. It will detail how to verify the products’ compliance with published regulations. It will also detail requirements for registration, labeling and acceptable marketing claims.

Recording Available

* Per Attendee $229

 

Comparing the Pharmaceutical and Medical Device Product Lifecycles

webinar-speaker   Howard Cooper

webinar-time   120 Min

Product Id: 704853

This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.

Recording Available

* Per Attendee $249

 

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

webinar-speaker   Norma Skolnik

webinar-time   4 hrs

Product Id: 704530

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

Recording Available

 

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   3 hrs

Product Id: 704356

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

Recording Available

* Per Attendee $429

 

Creating a Global Regulatory Plan

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703283

This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Attendees will also gain exposure to the elements and a methodology for global regulatory plan development and maintenance.

Recording Available

* Per Attendee $229

 

 

 

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