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OPDP FOR MARKETERS: MAXIMIZING MATERIAL DEVELOPMENT AND REVIEW – AN INTRODUCTION

 

OPDP FOR MARKETERS: MAXIMIZING MATERIAL DEVELOPMENT AND REVIEW – AN INTRODUCTION

On-line, 24/7 accessible, pre-recorded Interactive Program Designed Specifically for Marketers

This is an asynchronous course, approximately 4 hours in length, taught by Lucy Rose, designed for you to complete on your time and at your convenience.

Who Should Attend?

All life science marketers and their agency partners, in the US and all global regions, charged with designing marketing materials/programs to be used in the US

Course Description

This innovative course is a must for all new Pharma & Biotech marketers and their agency partners charged with designing marketing materials/programs to be used in the US. If you want to create impactful, compliant programs and materials AND increase the effectiveness and efficiency of your interactions with advertising agencies and copy approval teams, this program is for you. In addition to covering all of the regulatory basics you need to know, this program will address the new, rapidly evolving promotion and broader manufacturer communication environment. Lucy’s vast experience in industry regulatory, marketing and medical disciplines makes her uniquely qualified to provide this course and to provide colorful, illustrative stories regarding the “why” and “how” behind the regulatory requirements.

Utilizing the relevant laws, regulations, guidance, and actual FDA enforcement letters, Lucy will provide the reasoning behind the copy review team’s evaluation and interpretation of claims. OPDP for Marketers is a must for all marketers who want to improve their knowledge of the regulatory, legal, and medical requirements for creating successful, sustainable promotional materials, as well as for those who want to improve their strategic planning capabilities for designing effective and compliant launch and in-line campaigns.

This fully-recorded course is divided into 4 modules and includes numerous topics.

Topics covered include, but are not limited to:

1.    Current regulatory/legal/compliance environment (including FDA and other government agencies, payers, Congress, etc.), historical significance, and enforcement action examples.

2.    The FDA- who, what, why, how?

3.    Proven ways to most effectively work with your agencies and copy approval teams to maximize efficiencies and convert “no” to “yes.” Best practices.

4.    FDA regulatory requirements, including, but not limited to: truthful and non-misleading, consistent with labeling, fair balance, comparative claims data requirements, disease state communications, public relations and press releases, medical conventions/conferences, launch campaign development, internet, social media, Direct-to-Consumer promotion, FDA guidance documents and their potential impact.

Participants may NOT receive a refund for any reason.

Price: $750.00