Expert Details

Drug Regulatory Affairs (European Union)

ID: 729387 Germany

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Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany, the UK, France and Belgium. Expert has practical experience in all major European Union regulatory procedures, including the Centralised and Decentralised Procedures (CP, DCP), the Mutual recognition Procedure (MRP), Community Referral Procedures, Filing of Peadiatric Investigation Plans, Clinical Trial Authorization Applications, and various Lifecycle management fiings (variations, renewals, line extensions, periodic update reports). In addition, he has very good personal relationships to a number of key regulatory agencies in the EU, including the European Medicines Agency (EMA), the MHRA (UK), afssaps (France), Sanita (Italy), PEI and BfArM (Germany).
Expert's RA services comprise strategical advice as well as very much "hands-on" support in preparation and submission of regulatory documents. He also supports clients in preparaing and conducting Scientific Advice agency meetings and provides interim management services to clients.

Education

Year Degree Subject Institution
Year: 1993 Degree: PhD Subject: Pharmaceutical Sciences Institution: Ernst-Moritz-Arndt University of Greifswald (Germany)
Year: 1990 Degree: MS Subject: Pharmaceutical Sciences Institution: Ernst-Moritz-Arndt University of Greifswald (Germany)

Work History

Years Employer Title Department
Years: 2008 to Present Employer: Undisclosed Title: Owner Department: Regulatory Affairs Services Dr. Kintzel
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 2005 to 2008 Employer: Baxter Healthcare Title: Director Department: Global Regulatory Affairs
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 2003 to 2005 Employer: Elan Pharma Ltd Title: Senior Director Department: European Regulatory Affairs
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 1999 to 2003 Employer: Pharmacia Corp Title: Head, Regulatory Affairs, Germany Department: Regulatory Affairs Germany
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 1994 to 1999 Employer: Synthelabo Title: Head, Regulatory Affairs, Germany Department: Regulatory Affairs Germany
Responsibilities:
Available upon request.
Years Employer Title Department
Years: to Present Employer: Undisclosed Title: Manager Regulatory Affairs Department: Regulatory Affairs Germany
Responsibilities:
Available upon request.

Fields of Expertise

regulatory affairs, drug regulation

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