International Regulatory Cooperation Among Agencies 2015
8 January, 2015
Palm Beach FL , USA
Overview:
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made.
Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections. We will also discuss how reviews are being shared among regulatory agencies, and whether decisions by one country can be made on another country's review. 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
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
This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made.
Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections. We will also discuss how reviews are being shared among regulatory agencies, and whether decisions by one country can be made on another country's review. 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
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
Organizer
Compliance4All
18004479407
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International Regulatory Cooperation Among Agencies 8 January, 2015
