Regulatory Collaboration / 21st Century Innovation: Views of the Heads of Health Canada, the European Medicines Agency, and the US FDA
Hear views from the leaders of three of the most influential drug regulatory agencies:
European Town Hall Parts 1 and 2
- Health Products and Food Branch of Health Canada
- European Medicines Agency
- US FDA
EMA and national agencies’ senior leaders will discuss a number of important issues facing the European regulatory network.
Questions? Submit your questions in advance.
Discussion with Former Center for Devices and Radiological Health (CDRH) Management
Collaborative Partnerships in Drug Development: An Executive Roundtable Discussion
Join this moderated panel discussion with former CDRH Directors and Management. This interactive session will focus on the evolving face of medical devices, the interface between drugs and devices, new challenges and opportunities, and the changing regulatory landscape.
Hear from top executives as they share their vision for the future of pharmaceutical development.
Analysis and Impact of PDUFA V: How the Changes Will Affect the Work of Regulatory Affairs Professionals
Meta-collaborations: A Call to Action
Discuss how to organize and prepare for the PDUFA V agreement coming October 1, 2012.
What barriers are keeping ideas from turning into action? How can these barriers be broken to develop new models for innovation and collaboration? High-level thought leaders will address these questions and explore how industry, academia, government, and patients— through meta-collaborations—can take drug discovery to the next level.
Collaborative Research with Members of the Payer Community
This session will focus on the power of the payer as the crucial emerging factor in the potential commercial success of pharmaceutical products.
Challenges of Precision Medicine: Diagnostics, Reimbursement, Partnership Co-development
This session will leverage real-world evidence generated during product development and throughout the product lifecycle to improve the overall quality of patient care.
SFDA Town Hall
Latin America Town Hall
Representatives from the State Food and Drug Administration (SFDA), P.R. China will address your questions and provide updates on initiatives, guidances, and regulations in their country.
Join members of Latin American Agencies as they discuss country-specific bioethics regulatory frameworks and strategies.
Implementation of the Physician Payments Sunshine Act: Now What?
Representing a cross-section of interest areas, the panelists will take a serious look at the Affordable Care Act and its burdens and benefits, the potential impact on clinical research, the advantages offered by the resultant transparency, and how all of this will play out within the public and organized medicine.
India Regulatory Town Hall
Regulatory authorities of India will provide information on initiatives, guidances, and regulations.
Partnering for Impact in Global Health
Join representatives from the Bill & Melinda Gates Foundation to discuss the Foundation’s “Decade of Vaccines” effort. Panelists will address a partnership for tuberculosis drug discovery, provide examples of product development partnerships, and outline the project on postmarket drug and vaccine surveillance in low- and middle-income countries.
Orphan Drug Development: Global Regulatory Challenges and Initiatives
Discuss the crucial need for developing orphans drugs.
CBER Town Hall
Get updated on CBER’s latest guidances and initiatives.
CDER Town Hall: Parts 1
and Part 2
Discuss topics of current importance within the CDER communities. Questions? Submit
your questions in advance.