Date: | July 9, 2015 - 10:00am - 11:30am |
Timezone: | (GMT-08:00) Pacific Time (US & Canada) |
Location: | Fremont, CA, 94539, United States, Compliance4all |
Website for Event: | http://bit.ly/1GLLNZI |
Topic: | Medical Advice and Resources |
Description: | This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. Overview: We will discuss Tier 1, 2, 3, and other regulatory agencies and how the approach to international reviews varies from agency to agency. We will discuss whether the European paradigm can be applied more broadly, and what the impact of ICH and CIOMS has to the international sharing of data. Why should you Attend: 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 Who Will Benefit: Compliance4All |
Contact Name: | Adam Fleaming |
Contact Email: | support@compliance4All.com |
Contact Phone: | 8004479407 |