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Wednesday, June 27 • 4:00pm - 5:15pm
#396: Current and Future Perspective on Mutual Recognition, Work Sharing, and Global Regulatory Convergence

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-685-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will feature regulatory and industry experts highlighting efforts by World Health Organization (WHO), International Coalition of Medicines Regulatory Agencies (ICMRA) and other organizations to drive mutual recognition, work sharing, and regulatory collaboration and harmonization. After the short presentations, participants will divide into small groups to discuss ways to advance some of these efforts and identify opportunities for regulatory authority and industry engagement.

Learning Objectives

Discuss ways to advance harmonization and identify opportunities for regulatory authority and industry engagement.

Chair

Terrance Ocheltree

Speaker

Facilitator
Mic McGoldrick, MT

Facilitator
Tânia Teixeira, PharmD


Speakers
avatar for Mic McGoldrick

Mic McGoldrick

Associate Director Regulatory Policy and Compendial Affairs, Merck Sharp & Dohme Corp.
Mic currently is an Associate Director of Global CMC Policy at Merck. He has over 27 years experience with Vaccine and Biologics. For 15 years Mic worked in Regulatory Affairs on INDs, new product filings, post approval submissions globally, and evaluation of worldwide guidance's... Read More →
avatar for Terrance Ocheltree

Terrance Ocheltree

Executive Director, Regulatory CMC, Pharmtree Consultants, LLC
Terry established PharmTree Consultants, LLC, to help bio and pharma companies develop strong regulatory strategies and submissions. He served as a reviewer and Division Director at FDA, worked as a pharmacist and developed and manufactured most types of dosage forms, including combination... Read More →
TT

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →

Wednesday June 27, 2018 4:00pm - 5:15pm
Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Workshop