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Pharma Strategies in Latin America: The Keys to Success
April 5, 2016 @ 13:30 - 15:00 UTC+0
Pharma Strategies in Latin America: Keys to Success: A Special Two-Part Mapi + FDAnews Webinar
Part I: Tuesday, March 15th, 2016 at 1:30 pm EDT
Regional business and regulatory environment in Latin America; situation analysis and strategies for organizations seeking for sustained growth in life-science markets.
Part II: Tuesday, April 5th, 2016 at 1:30 pm EDT
Alignment and convergence of clinical-registration requirements, and business opportunities in the major life-science markets in Latin America: Argentina, Brazil, Colombia, Mexico and Commonwealth of Puerto Rico.
Fernando Ferrer, Head of Global Consulting in Business and Operations, Multinational Partnerships LLC
Fernando Ferrer is a proven business leader in life science with experience across different corporate and cultural environments, and speaker in industry related events. Mr. Ferrer is based in the US, and due to his professional career he lived also in Spain, Switzerland, Argentina and Brazil, and besides his global roles, has had experience working directly with 30+ countries.
Silvia Bendiner, Director Regulatory Affairs Latin America, Mapi Group
Silvia Bendiner joined Optum Insight Life Sciences, acquired by the Mapi Group, holding the position of Director, Regulatory Affairs Latin America. Ms. Bendiner has over 25 years of life sciences experience, including pharmaceuticals, biotechnology, medical devices, nutraceuticals, cosmeceuticals, translational therapy, generics, biosimilars and biologics working with human and animal medicines.
This two-part webinar will provide valuable insights into the regulatory, clinical and marketing landscape for any company doing or planning to engage business in Latin America, whether exporting, in local partnership or manufacturing within the region.
Get answers to these important questions by attending the webinar series:
1. What countries offer the greatest IP protection?
2. What countries are planning major regulatory changes in the next 12 months?
3. What countries offer the best partnership opportunities?
4. What countries have the strictest clinical trial requirements?
5. What countries have the most robust adverse events reporting rules?
6. What countries have the most complex post-marketing surveillance guidance?
The expert faculty will cover all aspects of the drug development cycle, from research and clinical trials to post-marketing surveillance, through the prism of the social, political, business and regulatory perspective in Latin America.
- Gain the latest insights and updates of ongoing regulatory convergence initiatives in Latin America.
- Find out where the real marketing opportunities are in the region — and how to take advantage of them.
- Become familiar with strategic partnering opportunities for clinical development, regulatory filings, marketing and commercialization of biopharmaceutical products.
- Understand the regulatory complexities of the region and the specific opportunities and challenges in Argentina, Brazil, Colombia, and Mexico.
- Discover the regulatory and legal rubric manufacturers will encounter in the drug development process, including unique clinical trial regulations, GMP requirements, approval obstacles and shortcuts, post-approval marketing standards, adverse event reporting and more.
- Determine what course of action is best in this region, in terms of investing dollars and resources in a growing, diverse but ambiguous (we recommend potential instead of ambiguous) environment.
Take an analytic peek at the future opportunities for biopharmaceutical development in the region.
This series will cover all companies need to know about entering the Latin American market from research and clinical trials to post-marketing surveillance and adverse event reporting.
Who Will Benefit From Attending:
· Medical Affairs Officers
· Director of Clinical Operations
· Regulatory Affairs Professionals
· Director of Publications
· Director of Clinical Trial Regulatory Management
· Clinical Trial Information Disclosure Directors
· Global Clinical Safety and Pharmacovigilance Officers
· Legal counsel
· Regulatory affairs
· Compliance officers
· Product lifecycle managers
· International Affairs
Archived Webinar Presentation(s):
This event has passed. See below for recorded slides and instructions on how to find out more from the presentation authors / webinar hosts.
Part I - See below for the PowerPoint presentation slides (audio not included):
Alternatively, you may view this webinar's Part I slides set via SlideShare (audio not included):
Part II - Request slides from our webinar hosts:
- Silvia Bendiner - Click here to email this host
- Fernando Ferrer, MBA - Click here to email this host
Additional learning resources from this webinar:
"A Checklist for Winning Marketing Authorization in Latin America"
Argentina, Brazil, Columbia and Mexico are four of the top five economies and pharmaceutical markets in Latin America, making them prime spots for drugmakers to do business. These four countries also have four of the seven agencies of reference of the Pan American Health Organization.