Strategies for Communicating with the FDA and Handling FDA Warning Letters

Event Information
3 Days
Left To Register
Product Format
Live Webinar
Conference Date
Add to my calendar   Wed, Oct 25, 2017
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
60 minutes
Product Description

Get Regulatory Insights and Tips for Successful Communication with FDA

In order to successfully market drugs and dietary supplements in the U.S. it’s essential to comply with FDA regulations and communicate with the FDA successfully to obtain FDA guidance. It’s very important to have proactive and reactive strategies for FDA communication, especially if there are regulatory issues or if you receive an FDA Warning letter.

In this session, expert speaker Norma Skolnik will cover strategies for effective communication with FDA centers and staff. Norma will provide regulatory insights, know-how and tips. She will also provide references to all relevant FDA regulations, guidance documents, and FDA websites.

Session Highlights

  • Pre-IND /NDA communications with FDA
  • Small business and industry assistance meetings
  • Initial communications prior to drug product launch
  • Initial communication prior to dietary supplement launch
  • Proactive and reactive strategies for FDA center communication
  • Practical approaches for communicating with FDA
  • Formal advisory request process
  • Responding to FDA warning letters

Who Should Attend

  • Regulatory affairs managers
  • Directors and associates
  • Compliance specialists
  • Marketing managers and anyone planning to market drugs or dietary supplements in the U.S.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...   More Info
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