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#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P; CME 1.00; RN 1.00

This forum will address the rise of illegal mass manufacturing of unapproved medicines, which threatens patient safety. Participants will discuss current regulations and the need for new rules to ensure drug supply chain integrity and promote safety.

Learning Objectives

Describe the landscape for the exponential growth in the distribution of unapproved or unauthorized medicines; Identify risks associated with illegal large-scale manufacturing of unregulated and untested compounded drugs; Discuss regulator perspectives on the issues relating to the mass distribution of unapproved medicines; Explain current regulatory frameworks and how to adapt them.

Chair

Brad Jordan, PHD

Speaker

TBD
Shabbir Safdar

Panelist
Andrew Funk, PHARMD, RPH

ANVISA Perspective
Renato Lopes Hurtado, MSC, RPH


Speakers
avatar for Andrew Funk

Andrew Funk

Director, Member Relations/Government Affairs, NABP, United States
Andrew Funk, PharmD, Director of Member Relations and Government Affairs, NABP Andrew Funk is the Director of Member Relations and Government Affairs for the National Association of Boards of Pharmacy (NABP). With more than a decade of experience in pharmacy regulation—including... Read More →
RL

Renato Lopes Hurtado

head the Management of Inspection and Health Surveillance of Medicines and Pharm, ANVISA, Brazil
Manager of the Medicines and Pharmaceutical Ingredients Inspection Department (GIMED) at Anvisa, the Brazilian Health Regulatory Agency. A pharmacist with a Master’s and a PhD candidate (UnB), he is a certified Lead Auditor (ISO 9001/19011). His career features extensive experience... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
SS

Shabbir Safdar

Executive Director, Partnership for Safe Medicines, United States
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety and the Imitation Nation "all things counterfeit" podcast. He sits on the editorial board of the Journal of Illicit Trade, Financial Crime, and Compliance... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

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