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ABOUT THIS WEBINAR (Hosted by CDER SBIA)

The goal of this webinar is to provide an introduction to FDA’s Office of Trade and Global Partnerships (OTGP). OTGP serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts. OTGP also serves as the FDA lead for addressing cross-cutting issues in multilateral organizations, such as the World Health Organization, and coordinates issues arising in multilateral forums within FDA.

Through the webinar, the audience will learn how OTGP’s work relates to pharmaceutical products and understand the different types of international agreements and arrangements used by FDA. The audience will also learn when and how to contact OTGP.

INTENDED AUDIENCE

• Manufacturers, consultants and professionals:
  • engaged or interested in international trade of pharmaceutical products and drug supply chain issues
  • who have an interest in understanding FDA’s pharmaceutical mutual recognition agreements with foreign regulators
  • involved in the development of pharmaceutical products and combination products that might be impacted by ongoing international negotiations to reduce the use of plastics
• Foreign regulators
• Trade associations

TOPICS

• A general overview of OTGP’s mission, roles, and activities
• Overview of international arrangements and mutual recognition agreements (MRAs) between FDA and foreign drug regulatory authorities and the impact of MRAs on pharmaceutical inspection process
• Why the FDA cares about international trade and OTGP’s role in addressing non-tariff barriers to trade in pharmaceutical products
• Implications of the United Nations (UN) plastics negotiations for pharmaceutical products

SPEAKERS

Joseph Rieras
Director
Office of Trade and Global Partnerships (OTGP) | Office of Global Policy and Strategy
(OGPS) | Office of the Commissioner (OC) | FDA

Eloisa Noriega
International Policy Analyst
OTGP | OGPS | OC | FDA

Azada Hafiz
International Policy Analyst
OTGP | OGPS | OC | FDA

Kristan Callahan
Senior Public Health Advisor
OTGP | OGPS | OC | FDA

Matthew Scherer
International Policy Analyst
OTGP | OGPS | OC | FDA

FDA RESOURCES

• Office of Trade and Global Partnerships
• Office of Global Policy and Strategy

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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