“ To Outsource or Not to Outsource”, the question that many of the companies may be asking.
The webinar aims to compare and contrast the advantages & disadvantages of conducting Regulatory Affairs from both a Sponsor/Manufacturers’ Point of View and from a RA Vendor’s Perspective.
Some of the Topics Covered are:
Should you consider outsourcing or not
What to Outsource & what not to
Share Practical Experiences
Date & Time :
Date: Wednesday, 26th August 2015
Time: 4 – 5 PM CET | 11 AM – 12 PM EST
Cost : None
Speakers: Dr. Alan A. Chalmers
Dr Alan A. Chalmers is a pharmacist with over 35 years’ industrial experience mainly in the field of pharmaceutical regulatory affairs.
A graduate of Strathclyde University in Glasgow with a B.Sc. in Pharmacy with specialization in Pharmaceutical Technology, his Ph.D. at Manchester University was in Pharmaceutical Formulation.
After a few years 1975-1978 as Pharmaceutical Development Officer and Clinical Trials Pharmacist of Allen & Hanburys (part of the then Glaxo group), he joined Ciba-Geigy in DRA in 1978. Over 20 years were spent with Ciba-Geigy/CIBA/Novartis in all aspects of regulatory affairs including head of a group company DRA in Canada and for many years as Head of Pharma International regulatory affairs with global regulatory responsibilities for both new products and product maintenance.
Dr. Chalmers has been a consultant to the IFPMA, WHO and other international bodies and was Chairman of the Organizing Committee of the initial IFPMA Asian Regulatory Conferences in Hong Kong and Singapore and Rapporteur to the more recent conferences in China and Malaysia.
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It’s a journey of 15 years with clients from across the Globe providing a broad range of knowledge-based contract research and consulting services to the worldwide pharmaceutical, biotechnology, and medical device industries. MakroCare has successfully helped clients launch products or expand into newer regions. Services included Regulatory Strategy to getting product approvals globally to maintain compliance. By effectively “productizing” knowledge and experience in the form of Regulatory Affairs Center of Excellence (RACoE), MakroCare has helped clients either accelerate their projects or save costs. MakroCare has developed Multi-Dimensional Regulatory Service Accelerators (NAVAT) that is helping companies to accelerate their Global Submissions and receive faster Approvals. In addition, our functional services include CMC Authoring, global submission management, LCM, Labeling & affiliate support.