What you need to know to submit Study Data to FDA
The appointment of two key experts demonstrates the Group’s commitment to providing a consistently high level of service
Friedrichsdorf, January 25th 2017: As at 2nd January, 2017, the PharmaLex Group, a leading specialist provider of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has enhanced its team with two key appointments.
Carolyn Belcher joins PharmaLex as Executive Vice President Development Consulting & Scientific Affairs. Carolyn has over 25 years’ experience within the Health Care Industry, including more than 14 years heading up various regulatory affairs and strategic drug development teams for five different legacy CRO’s. Before moving into full management, Carolyn managed projects and assignments for different areas of regulatory affairs, from early phase research and development, pre-approval submission through to marketing authorizations as well as post-approval and maintenance activities. Carolyn has been involved in the regulatory development and marketing activities for small molecules, various recombinant proteins and vaccines, spending 18 months working on an annual flu vaccine together with associated R+D activities. Prior to joining the CRO industry, Carolyn was employed by Novartis and before that the UK National Health Service as a Clinical Research Scientist working within the field of cardiothoracic transplantation. Her therapeutic areas of interest include: transplantation, respiratory, cardiovascular and vaccines. Carolyn holds an MBA; MPhil; MSc. Carolyn is based in the UK and joins PharmaLex from ICON plc, where she was Head of Global Regulatory Affairs.
Lutz Wevelsiep joins PharmaLex as Senior Director, Principal Consultant Development Consulting & Scientific Affairs. Lutz has more than 25 years’ experience in international Regulatory Affairs across Europe and the US within multinational and start-up companies. His extensive experience includes EU decentralized and centralized procedures, product development from Phase I through to marketing authorization as well as particular expertize in anti-infectives. He has prepared and managed various health authority interactions with FDA, EMA and EU national agencies. Lutz is based near the German-Swiss border and joins PharmaLex from Basilea Pharmaceutica, where he has spent the past 16 years as Head of Global Regulatory Affairs. Lutz’s appointment will help PharmaLex broaden its reach within Switzerland, providing essential local knowledge and expertize.
“It is important that we continue to strengthen our team and both Carolyn and Lutz come to us with a wealth of experience” explained Dr. Thomas Dobmeyer, CEO PharmaLex. “We are in a highly competitive market and having the ability to enhance our service lines with specialists who are at the top of their industry, is a key attraction for our clients” added Dr. Tilo Netzer, CEO PharmaLex.
The PharmaLex Group now has over 650 employees, with 25 offices in 14 countries and more than 600 satisfied clients worldwide.
About PharmaLex <Confidence beyond compliance>:
PharmaLex combines local expertise with global reach in the area of scientific services, regulatory affairs and pharmacovigilance. A proven track record of success in outsourcing programs with more than 25,000 successfully completed projects for over 550 clients worldwide, as well as extensive experience in all therapeutic areas and product groups, including advanced therapy medicinal products and biopharmaceuticals, medicinal and borderline products and alternative therapeutic approaches.
For further information, please contact:
Ms. Eva Keck
Director Business Development Operations, PharmaLex GmbH
eva.keck@pharmalex.com
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim
Germany
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