Senior Consultant

Ricarda Meincke

Ricarda is an expert in Swiss regulatory strategy and a former regulator. With a wealth of experience in managing submissions for NMEs and biologics to Swissmedic, Project Orbis, and the ACCESS Consortium. She excels in helping companies navigate complex regulatory challenges and providing strategic guidance on the most optimal approval pathways available throughout the drug development process.

Key areas of expertise
  • In depth experience in MAA, BLA and biosimilar submissions to Swissmedic, including expedited review and reliance pathways 
  • Extensive knowledge of Swiss authorization pathways, including Article 13, New Active Substances, Fast Track Procedure, Procedure with Prior Notification, Temporary Authorizations, new indications and line extensions.
  • Former member of international regulatory collaboration initiatives, contributing to the implementation of Project Orbis and ACCESS NASWSI procedures at Swissmedic and managing various submissions under these initiatives.
  • Product life cycle management, PEL applications and Orphan Drug Designations for Switzerland
  • Regulatory project management for filings under ACCESS Consortium and Project Orbis
  • Oncology, cardiovascular diseases and Orphan drugs
Before NDA

Ricarda worked for Swissmedic as Regulatory Manager (2016-2022) managing a portfolio of products, including those for the treatment of cardiovascular diseases and cancer.
A member and co-cordinator of the ACCESS (Australia, Canada, Singapore, Switzerland UK) Consortium, New Active Substance Work-sharing Initiative (NASWSI) working group and led various small molecule submissions under the ACCESS work sharing pathway.
She was also a Project Orbis coordinator at the agency, involved in various MAA, BLA and new indication filings under the FDA led parallel review initiative.

Ricarda holds an MSc in Pharmacy, Charles University Prague, and a BSc in Biochemistry, Brigham Young University Hawaii.

Recent Publications

Hotaki LT, Shrestha A, Bennett MP, Valdes IL, Lee SH, Wang Y, Spillman D, MacAulay T, Hunt M, Gervais J, Mafi M, Panetta V, Looi YH, Shum M, Atiek E, Meincke R, Rohr UP, Ainbinder D, Boehm-Cagan A, Luxenburg O, Cerqueira MR, Mouawad LS, Thees MFRES, Prasad K, de Claro RA. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners. Ther Innov Regul Sci. 2023 Jul;57(4):875-885. doi: 10.1007/s43441-023-00522-4. Epub 2023 Apr 18. PMID: 37072651.

Tam A, Garcia-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodriguez Martinez Z, Divinsky M, Kariv R, Potthast H, Braddy AC, Rodrigues C, Guzman Aurela E, Carolina Arevalo Gonzalez L, Gutierres Triana D, Jones B, Ahn C, Kim H, Kim SH, Kuribayashi R, Myoenzono A, Shimojo K, Van Oudtshoorn J, Bigler C, Meincke R, Roost MS, Walther C, Hsu LF, Crane C, Jarman T. A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme. J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081. PMID: 36251699.

 

Ricarda Meincke

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