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Photo, Dr. Christian Alejandro Lopez-Silva

Dr. Christian Alejandro Lopez-Silva

Partner
Baker & McKenzie Abogados, S.C.

Biography

Dr. Lopez Silva is the head of Pharmaceuticals & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the Latin America Pharmaceuticals Group. He has more than 14 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

Practice Focus

Dr. Lopez Silva regularly advises on regulatory, transactional and intellectual property matters for the manufacturing, import, distribution, advertising, labeling, commercialization and post-market vigilance of medicines, medical devices, food and beverages, cosmetics, seeds, veterinary products, chemicals, alcohol and tobacco.

He has experience in government relationship, administrative proceedings, registration of products, as well as consultancy and contractual work

Representative Legal Matters

  • Designing and executing a strategy for a German pharmaceutical company in relation to the pre-submission regulatory meeting with the New Molecules Committee.
  • Advising an Italian chocolate company on issues relating to the use and labelling of food additives, including a government relationship strategy to obtain ruling requests from the Sanitary Authority.
  • Advising a US pharmaceutical company to implement the linkage system between patents and health authorizations in Mexico.
  • Advising a US herbal products company to register products in Mexico, including dietary supplements, herbal remedies and herbal drugs.
  • Advising a US pharmaceutical company on several contractual and regulatory issues relating to clinical trials.
  • Advising an Argentinian contract research organization on regulatory approvals for research protocols and import/export permits.
  • Advising a French medical devices company on the rules for promoting and advertising products during different stages in their life cycle.
  • Advising a US medical devices company in a global transaction to sell a division on specialized medical equipment.
  • Advising several pharmaceutical companies on the new regulatory framework for biotechnological drugs and biosimilars in Mexico.
  • Advising several pharmaceutical companies on how to navigate the changing regulation of orphan drugs in Mexico.

Professional Associations and Memberships

  • Health and Life Sciences Committee for the IBA (International Bar Association) based in London - Member
  • The Food and Drug Law Institute (FDLI) based in Washington DC - Global Committee Member
  • Mexican Association for Health Law and Regulation (AMDERSA) - Founding President
  • British Chamber of Commerce in Mexico - Life Sciences & Healthcare Business Group - Member
  • American Chamber of Commerce - Working Group on Sanitary Affairs - Coordinator
  • International Law Association - Committee on International Law on Biotechnology based in London - Member

Admissions

  • Mexico (2001)

Education

  • University of Sheffield (Ph.D. Life Sciences International Regulation) (2008)
  • University of Sheffield (Master's Degree Biotechnological Law and Ethics) (2003)
  • Instituto Tecnológico Autónomo de México (J.D. Honors)

Languages

  • English
  • Spanish