Training Courses

Offers tailor made courses within global requirements for Drug Development and regulatory approval (early Development to life cycle management) for biological medicines.

• Biosimilars: Has actively contributed to regulatory guidelines and pathways for biosimilars, has in-depth understanding and experience of the scientific basis for biosimilar guidelines. Supports international development of biosimilar regulations by training both industry and regulatory authorities on biosimilar regulations and scientific basis for data requirements (a list of presentations is show in About).
• ICH guidelines

Teaching experience:

• APEC Biotherapeutics and Biosimilars Training courses (2017-)
• APEC Multi-Regional Clinical Trials, ICH E17 focus (2017-)
• Copenhagen Business School (CBS), BioBusiness and Innovation Platform: Regulatory Affairs (2012-2014)
• Copenhagen University, Master of Industrial Drug Development: Downstream Processing (approx. 2002-2006)
• Massachuset Institute of Techology (MIT): Advanced Downstream Processing Summer Course (1999-2009)