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 Expert  729387

Expert in Drug Regulatory Affairs (European Union)


Available for your Consulting and Expert Witness Needs

Germany
Education Work History Consulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

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.
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regulatory affairs

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drug regulation


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution   Honors
1993   PhD   Pharmaceutical Sciences   Ernst-Moritz-Arndt University of Greifswald (Germany)   Summa Cum Laude
1990   MS   Pharmaceutical Sciences   Ernst-Moritz-Arndt University of Greifswald (Germany)   Magna Cum Laude

Work History:
Years   Employer   Department   Title  

2008 to

 

(Undisclosed)

 

Regulatory Affairs Services Expert

 

Owner

 

2005 to 2008

 

Baxter Healthcare

 

Global Regulatory Affairs

 

Director

 

2003 to 2005

 

Elan Pharma Ltd

 

European Regulatory Affairs

 

Senior Director

 

1999 to 2003

 

Pharmacia Corp

 

Regulatory Affairs Germany

 

Head, Regulatory Affairs, Germany

 

1994 to 1999

 

Synthelabo

 

Regulatory Affairs Germany

 

Head, Regulatory Affairs, Germany

 

to

 

(Undisclosed)

 

Regulatory Affairs Germany

 

Manager Regulatory Affairs

 

Consulting Services:
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert witness MHRA for consulting on EMA/MHRA.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
German   Native speaker
French   Sound comand
Englísh   Sound comand

 

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