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Tuesday, June 18 • 4:30pm - 5:30pm
#289: Post-COVID cGMP Inspections by Global Regulatory Authorities

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.

Learning Objectives

Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.

Chair

Lan Mu, PhD, RAC

Speaker

Industry Update
Karthik Iyer, MS

EU Update
Kheira Hamadi

Panelist
Erica Franca Costa, RPh


Speakers
avatar for Lan Mu

Lan Mu

Senior Vice President, Bio-Thera Solutions, United States
Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →
EF

Erica Franca Costa

Health Regulation Specialist, ANVISA, Brazil
Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →
KH

Kheira Hamadi

GMP Inspector, ANSM, France
avatar for Karthik Iyer

Karthik Iyer

Director, Global Quality, Merck & Co., Inc., United States
Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Forum