Dr. Martin Haerer
Dr. Haerer graduated in 1986 from the University in Tübingen with a degree in Pharmacy. His doctorate was completed in 1990 (summa cum laude) with a thesis written about Analytical Chemical Pharmaceutical Processes. A Master Degree in Pharmaceutical Technology was also given. After 1990 he began a carrier in the pharmaceutical industry with Rommelag CMO working in different area: Production, Quality Control and Quality Assurance. Rommelag CMO is a company that specializes in aseptic Blow Fill Seal manufacturing with various regulatory approvals (e.g. FDA, EMEA, Brazil, and Japan). In 2006 he has worked as Production Manager and Qualified Person (QP) for all the companies manufacturing sites. Recently he became responsible for Business Development, Technology Transfer and Research and while still acting as Qualified Person with QA responsibilities.
Dr. Haerer was the Task Force Leader for the PDA Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, Board Member (regulatory officer) for the Blow/Fill/Seal International Operators Association (BFSIOA), Member of the German QP Association, Board Member of Federal German Pharmacist Advanced Training Organization (BAK).
, General Manager, Rommelag
Mr. Kram is an Engineer and pharmaceutical business development professional, and is presently the General Manager for Rommelag Engineering’s US office. For the past 15 years he has provided aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology, and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations. In the past Mr. Kram has worked as a process engineer, filtration specialist, project manager and service engineer. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology in 1991.
Mr. Kram is an active member in the PDA, task force member Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, task force member Technical Report 27 update: Pharmaceutical Package Integrity, ISPE member, AAPS member.