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AGENDA: PRECONFERENCE
Tuesday, August 21, 2007
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12:00 p.m. |
Registration
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Preconference Symposia (Choose one Preconference only)
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Pre-conference Workshop I: DDMAC and Compliance 101: A Primer
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1:00 p.m. |
In this interactive session, attendees will learn to:
- Discuss the latest regulations, enforcement actions, guidelines, and trends affecting the advertising and promotion of medical devices, drugs, and biologics
- Describe how companies can best navigate the FDA regulatory review process
- Provide an overview of the current direct-to-consumer advertising/promotion environment
- Outline the latest policies and actions being taken by the Office of Inspector General (OIG) and Department of Justice (DOJ)
- Summarize the FDA's claim support and fair balance regulatory requirements
- Facilitate proper promotional practices at medical meetings
- Comply with interactive communications regulations on the Internet
- Present best practices in sales force and speakers' bureau monitoring
- Recognize regulatory/compliance challenges associated with public relations and disease state programs
Tom Casola, MBA, Executive Director, Commercial Operations, Merck & Co., Inc., North Wales, PA
Presentation Material (Acrobat)
Kelly Freeman, PhD, MSc, Director, US Affiliate, Compliance and Ethics, Eli Lilly and Company, Indianapolis, IN
Presentation Material (Acrobat)
Presentation Material (Powerpoint)
Lucy Rose, MBA, President, Lucy Rose and Associates, LLC; Former Director of the Office of Training and Communications and DDMAC, CDER, FDA, Roseland, VA
Permission to Post Materials Not Provided
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5:00 p.m. |
Adjournment
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Pre-conference Workshop II: Risk Avoidance Writing: Secrets for Avoiding Liability and Creating Accurate, Powerful Documents in FDA-Regulated Industries
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1:00 p.m. |
In this interactive session, attendees will learn:
- 4 types of information never to include in documents
- 7 ways poorly written documents can come back to haunt you
- 6 tips for grabbing your reader's attention
- 10 techniques for keeping your reader's eyes glued to the page
- 5 tricks to improve your proofreading skills by 95%
- 9 grammatical secrets to avoid errors that even educated people make.
Plus...take home 4 Bonus items:
- Memo Template for requests to management that will save hours of time
- Email Template to ensure your emails get read and acted upon
- Proofreading Handout with tips and symbols to share at work
- Grammar Cheat-Sheet for easy, confident reference
Linda Rivero, President, Voice of Persuasion, Alexandria, VA
Nancy Singer, President of Compliance-Alliance; Former Prosecutor, U.S. Department of Justice, Washington, DC
Permission to Post Materials Not Provided
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5:00 p.m. |
Adjournment
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