International Regulatory Cooperation Among Agencies
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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 further
- How Pharmacovigilance impacts international harmonization
- How ICH and CIOMS impact international harmonization
- Inspections and GMP approached internationally
Who Will Benefit:
- Director of Regulatory Affairs
- Manager of Regulatory Affairs
- Director of QA
- Manager of QA
- Director of Marketing
- Safety Director
- Director of PV
Anne Tomalin has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies.
Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005).
Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.
Anne founded CanReg Inc. in September 1996. CanReg was acquired by OptumInsight in December 2009. Prior to founding CanReg, Anne was employed for 20 years with Searle Canada, A Unit of Monsanto Canada Inc. as Business Unit Director. Responsibilities in the last several years at Searle included regulatory affairs, provincial government, reimbursement strategies, managed care, customer interface, legal and information services. Prior to joining Searle, Anne was employed by Hoffmann-LaRoche Limited for three years.
Prior to Roche, Anne was employed for three years by Wyeth Ltd. Anne has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association of Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA).
In Canada, Anne has also chaired the Manitoba, Saskatchewan and Ontario Committees for the Pharmaceutical Manufacturers Association of Canada (PMAC), now Rx&D, and she has worked with the Nova Scotia Department of Health to revamp their drug formulary. Anne is also engaged in teaching several regulatory courses to industry, including inhouse training courses for several large companies.