Pharma Strategies in Latin America - Webinar CD/Transcript

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Pharma Strategies in Latin America: Keys to Success Special Two-Part FDAnews Webinar

This two-part webinar CD and transcript 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:

  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?

Our 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.

Session takeaways:

  • 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 you can 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 you’ll 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 for your company 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 webinar CD and transcript will cover all you need to know about entering the Latin American market from research and clinical trials to post-marketing surveillance and adverse event reporting.

  • 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

Meet Your Presenters

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.