What current regulatory, global, and public opinion trends have the potential to impact biologics?

Regulatory Affairs for Biologics
June 23 from 9:00AM – 5:00PM in Boston

Participants in this tutorial will learn the differences between traditional biologics and biotechnology products, the regulatory needs and requirements for biologics, the unique aspects in the development of specific biologics such as vaccines and gene therapy, and the different ways that CBER and CDER view product development.

Instructor:
Carol H. Danielson, DrPH,MS
President
Regulatory Advantage, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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Global Regulatory Track at DIA's 49th Annual Meeting

CBER Town Hall: Ongoing initiatives, guidances, and regulations

CDER Town Hall: Hot topics in drug development and regulation (part 1)/(part 2)

PMDA Town Hall: Japanese regulation activities and initiatives

What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?

What is the current regulatory system and government R&D program?

European Town Hall: Implementation of New Safety Legislation

What do stakeholders need to know about the Canada-US #RCC?

What is the current drug supply situation in US, EU and Japan?

What are Canadian approaches to Regulatory Modernization and Int'l Engagement?

Latin America Town Hall: How are LA regulations modeled after and differ from EMA and FDA regulations?

Global Regulatory Track at DIA2012

Global Regulatory Track

Interact with global regulators to create a new, more efficient collaborative paradigm to share information, experiences, and develop strategies to improve medical product development. This track seeks to establish mechanisms to facilitate the exchange of information, share best practices, identify commonalities, and develop approaches to overcome regulatory barriers.

• CDER Town Hall: Parts 1 and 2
• CBER Town Hall
• European Town Hall: Parts 1 and 2
• Indian Town Hall
• International Regulatory Cooperation: A Canadian Perspective
• Latin American Town Hall
• Pediatric Drug Development Progress: 15 Years Later and Across the Globe
• Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
• SFDA Town Hall
• State of Electronic Submissions at CDER, CBER, and CDRH
• Update from the EMA-FDA Parallel Assessment Pilot
• Update on EMA, FDA, and PMDA International Activities

For more details, please visit Global Regulatory offerings at DIA 2012.

Collaborate to Innovate