Course Description
This training sessions highlight the implemented regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, and Peru.
The course will cover topics relating to pre-clinical and clinical requirements, as well as presenting the matrix of regulatory agencies in Latin America. Sessions will include:
- Descriptions of the methods by which counterpart agencies approve product submissions and registrations
- What is expected in the authorization and application submission of licensed products
- Part 11 application of electronic record systems and case report form regulations
- Discussion on importing and exporting your test article including logistic considerations
- Common pitfalls that have caused regulatory difficulties for global health care product providers in the region
- Responding to your host countries regulatory concerns and providing the FDA with this information
The current regulatory climate in Latin America will be illustrated in depth and will include workshops with real world scenarios. Sessions also include Latin American health agencies implementation of ICH standards and how they relate with FDA & European Medicines Agency (EMA) standards.
A final 45 question assessment will be provided.
Who Should Attend
This two-day course will benefit regulatory personnel whose responsibilities require knowledge of Latin America’s regulatory environment. Sponsors and research staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant.
Shipping and Logistic team members, General Management and Sales employees requiring an understanding of how regulations and compliance issues impact the organization will also benefit from this program. (Sponsors of biologics, drugs and devices).
Learning Objectives
This training program is designed to introduce the regulatory landscape in Latin America
with sessions that include:
- Latin American Regulatory Matrix (Primary Focus will be on Brazil and Argentina)
- Sponsor specific procedures for Pharmaceuticals, Medical Devices, Biologics, and Combination Products
- Client relations and collaborating in Latin America
- Regulatory requirements which often update annually
- Communicating with Latin American Regulatory Agency personnel
- The art of negotiating with Latin American regulators without getting lost in translation
- Institutional Review Board considerations to balance FDA & Latin American regulations
- Best practice procedures for delivering translatable submissions
- Best practice planning matrix for expedited approval for the health product application process
- Logistics and accountability of Authorized Products
Past Participants' Comments
Course Locations
