Regulatory Panel

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Tuesday, September 15, 2020: 8:00 AM - 9:30 AM

SESSION CHAIRS & SPEAKERS

Speaker
Jean Mulinde
Division of Clinical Compliance Evaluation
CDER, FDA
Session Chair
Jonathan Andrus
M.S., CQA, CCDM, Chief Business Officer
Clinical Ink, Inc.
Speaker
Kassa Ayalew
Supervisory Medical Officer/Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation, CDER
FDA
Speaker
Lisbeth Bregnhøj
MSc Pharmacy, PhD, Medicines Inspector, GCP and GVP
Danish Medicines Agency
Speaker
Mandy Budwal-Jagait
GPvP Operations Manager and Senior GCP Inspector, MHRA
MHRA
Speaker
Ni Aye Khin
Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER
FDA

SESSION DESCRIPTION 

The annual SCDM Regulatory Forum will offer participants an opportunity to engage our panelists from the FDA, EMA and MHRA on current key topics concerning Clinical Development and the Data Management discipline. In addition to specific updates the panelists will provide, participants will be offered to the opportunity to ask their questions during the Q&A portion of the session. Do not miss the chance to determine what is critical to our regulators, to your peers, to you and your organization.

Panelists will be answering your questions to determine the most critical industry challenges and to provide the relevant guidance you require. Please submit your questions by September 7.

Submit your question now! 


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