Regulatory Interactions with Health Authorities

Instructor: Martin Lessem
Product ID: 706330
  • Duration: 90 Min
This course will focus on Regulatory Interactions with Health Authorities. It will go over the basic types of meetings, correspondence, and committees which companies may use to interact with Health Authorities.
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Why Should You Attend:

Regulatory Interactions with Health Authorities are what drive the drug development process. These are the meetings, correspondences, and committees which enable companies to chart a path forward with the approval of Health Authorities to finalizing drug and biological development. This course will also cover some strategies for dealing with differences in Health Authority opinions.

  • Gain a better understanding of communications and interactions with Health Authorities
  • Better understand reasons for communicating with Health Authorities
  • Understand the importance of Health Authority Communications drug or biologics development
  • Understand the roles of various divisions, especially Regulatory, play in these communications

Areas Covered in the Webinar:

  • Differences between various types Meetings and Committees
  • Understanding of Health Authority communications
  • Time Frames for Communications
  • Roles during communications
  • When to run Mock Meetings and why
  • The Meeting Request and Briefing Book
  • Differences between FDA and EMA Meetings
  • Aftermath of Meetings

Who Will Benefit:

  • Regulatory Affairs, Quality Assurance, Medical Affairs, Clinical Development, Pharmacovigilance, CMC, Manufacturing, Marketing

Free Materials:

  • Rule documents or guidance
  • Slide Show
  • Checklist
Instructor Profile:
Martin Lessem

Martin Lessem
Principal Consultant, Lessem Regulatory Consulting LLC

Martin A. Lessem, J.D. is a professional with 17 years of experience in Pharmaceuticals. In the past 12 years he has been heavily involved with Regulatory Risk Management and worked on many of the larger industry programs. He has worked at large companies, small companies, innovator companies, and generic companies and has worked in risk management in all those settings. Currently, he is a consultant to Pharmaceutical companies on Regulatory Strategy and Risk Management.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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