International Regulatory Cooperation Among Agencies
July 9, 2015 - Online event CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. Understanding how agencies are impacting one another is fundamental to taking a product to approval on an international basis. Your approach to one agency might impact the decisions being made by another agency. It is also possible to use this approach to bring your product to market sooner in more jurisdictions. This newly emerging area is key to understanding the international registration of a drug or biologic. Those who understand what is happening and flex to work with it will find advantages in their global regulatory approach. Areas Covered in the Session: View of Regulatory Agencies to sharing data What can be shared and what is confidential Current status of meetings of Regulatory Agencies What are cluster meetings and when are they occurring What are Tier 1, Tier 2, their 3 and other regulatory agencies How countries are working together to improve the efficiency of review of generic submissions. Using international reviews to gain approval Could the European paradigm be expanded further How Pharmacovigilance impacts international harmonization How ICH and CIOMS impact international harmonization Inspections and GMP approached internationally Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1GLLNZI support@compliance4all.com www.compliance4all.com