Alejandra Del Río

Regulatory Affairs Manager

adelrio@carey.cl
+56 2 2928 2766

Senior Patent and Regulatory Specialist of Carey’s Pharmaceuticals and Biotechnology Group. Her work is focused on substantive processing of patents of invention in the pharmaceutical area, and in the preparation and processing of medical records for pharmaceuticals and cosmetics. She also has extensive experience in the tramitation of permits for the use and marketing of food and medical devices.

REPRESENTATIVE EXPERIENCE

  • Shire on its incorporation in Chile, including the transfer of its sanitary registration, preparation of regulatory agreements, corporate structuring, inter-business agreements and labor and tax issues.
  • Novartis on sanitary registration with data exclusivity protection of the product Entresto (sacubitrilvalsartan). The product was granted registration, but key and pivotal clinical trials were excluded from data exclusivity protection. The strategy included filing for a reversal remedy to revert such exclusion, which was successful and achieved the goal of securing full and complete data exclusivity protection for Entresto. This was a landmark case which set new administrative jurisprudence as, for the first time, the Public Health Institute (“ISP”) recognized data exclusivity protection for clinical studies which have partial disclosure in foreign voluntary publications.
  • Cargill on sanitary authorization of more than twenty animal food products and additives from the Chilean Livestock and Agricultural Service (“SAG”).
  • A leading international pharmaceutical company on the prosecution process of sanitary registration of pharmaceutical products and maintenance of registrations in force.
  • A leading international pharmaceutical company on the transfer process of their sanitary registrations of pharmaceutical products and authorization of the entity from the sanitary authority.
  • A leading pharmaceutical company on the defense of their products category before the Public Health Institute (ISP) for their recognition as reference products in the bioequivalence system in Chile.
  • Several innovative pharmaceutical companies on submitting and obtaining their rights of undisclosed information about their pharmaceutical products.
  • A leading innovative pharmaceutical company on the defense of their rights of undisclosed information obtained in the sanitary registration.
  • A leading cosmetics international company on obtaining sanitary registrations of cosmetics and maintenance of registrations in force.
  • A leading international pharmaceutical products company on the defense of the phytopharmaceutical sanitary registration.
  • A leading international foodstuff company on obtaining the authorization for the entry and trading of their products.
  • Several leading international companies on the prosecution and defense of their industrial property rights concerning their pharmaceutical patents.

ACTIVITIES AND MEMBERSHIPS

  • Invention Patents’ Registrar, Chilean Patent Office (1995–2000).
  • Regulatory Matters and Technical Director, Pfizer Chile (2000–2005).
  • Professor of Pharmaceutical Legislation, Faculty of Chemistry and Pharmaceutical Sciences, Universidad de Chile (since 2009).
  • Professor of the Degree in Regulatory Affairs of Medicaments, Cosmetics and Medical Devices, Chemical and Pharmaceutical Sciences Faculty, Universidad de Chile (since 2009).
  • Professor of the Master’s Degree Program in Pharmaceutical Sciences, Advanced Pharmaceutical Engineering and Technology, Universidad de Chile (since 2009).
  • Professor of the Doctorate in Pharmaceutical Sciences, Universidad de Chile (since 2009).
  • Professor, Elective Undergraduate Course in Specialized Training, Universidad de Chile (since 2014).
  • Professor, Supervisor of extended practices and Professor Member of the Degree Thesis Commission for obtaining the Degree of Pharmacist in Regulatory Affairs, Universidad de Chile (since 2009).


Education

  • Chemical Pharmacist, Universidad de Chile (graduated with maximum distinction).
  • Degree in Quality Management and Leadership, Universidad de Chile (2000).
  • IP Courses, World Industrial Property Organization, Geneva, Switzerland.
  • Training Courses in examination and searches of patent applications in INAPI, EPO, OEPM and OMPI.

Languages

  • Spanish.
  • English.


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