Call Us : 1-646-216-8860
Live Corporate Webinar : Tuesday : 23rd October, 2012
02:00 PM EDT | 11:00 AM PDT

REGISTER NOW
Harmonization in Biosimilars: EU and FDA Acceptance of Foreign Reference Products
Presented By : Dr. Hoss A Dowlat & D. Christopher Ohly
Duration of webinar : 90 Mins | Duration of Q/A session : 10-15 mins
Deliverables : Copy of presentation slides will be shared
 
Short Abstract:
EU Commission/EMA to accept non-EU or non-EEA reference medicinal product for biosimilar MAAs
     European biosimilars developer have been faced with a legal requirement to use an originators reference product approved by and used in the EU in conducting studies to demonstrate biosimilarity. The EMA has recently announced that it will accept some clinical tests using reference product materials of foreign origin.


This presentation will cover the following areas :
  • Current information about the new EMA policy and it potential effects on the newly released EU guidances on biosimilars containing monoclonal antibodies (mAbs) and other proteins.
  • The biosimilar consultation “cluster” of the EMA and FDA will make advancement with this announcement. This opportunity will be explained
  • Examples of implications of the new policy in drug development.
  • Approaches to approval of biosimilars in the EU and US in light of the newly announced EMA policy.
  • This webinar and dialogue will focus on the far reaching importance of the new EMA policy to allow foreign reference products.
  • The regulatory and legal experts speakers will provide strategic insights into the impact of EMA announcement on biosimilars international development particularly US/EU.
Who Should Attend :
Biotech and Pharma companies/professionals interested in Biosimilars/Biologics/Biomarkers including:
  • Biosimilar Strategies
  • Clinical Affairs
  • Business Development
  • Product Development
  • Project Management
  • Regulatory Affairs
  • Sales and Marketing
REGISTER NOW
Upcoming Webinars

Optimizing Site Selection for Global Clinical Trials

- 26th Oct,2012 | 02:00PM EDT | 11:00AM PDT
more...
The new concept of Effective Risk Management : Are we ready for the implications of the recent changes?
- 26th Oct,2012 | 02:00PM IST | 09:30AM BST
more...
ISO 14971 : Risk Management for Medical Devices
- 2nd Nov,2012 | 02:00PM EST | 11:00AM PST
more...
FDA’s General Controls for Medical Device Manufacturers
- 9th Nov,2012 | 02:00PM EST | 11:00AM PST
more...
Optimal clinical supply planning for global drug development
- 16th Nov,2012 | 02:00PM EST | 11:00AM PST
more...
Speaker Profile:


     Dr. Hoss Dowlat, was until 2010, Vice-President, Technical, Drug Development Global Strategy Services, responsible for EU, USA, Japan, China, Korea, and Latin America drug development and regulatory submissions at the leading CRO PAREXEL. He now leads an outstanding new international team. He was with PAREXEL CONSULTING 2000-2010 and provided a direct consulting service to more than 50 client companies from Europe, America, Canada, Korea, Japan, and India. He is British-Canadian educated in England to B.Sc. and PhD level, and was also a recipient of a Post-doctoral European Royal Society Fellowship award in organic chemistry. He has over 31 years of experience in the European and North American pharmaceutical industry, 21 years of which have been in regulatory affairs. more...

     D. Christopher Ohly is a partner with Schiff Hardin LLP, resident in the firm's Washington, D.C. office. He has been a lawyer for more than 35 years. He has tried a large number of cases in a number of federal and state courts and regulatory agencies. With extensive background in other litigation that provides him with insights into business management, securities litigation and valuation, Mr. Ohly now concentrates his practice in complex intellectual property matters, especially Hatch-Waxman generic pharmaceutical litigation. He has advised and participated in all aspects of litigation, serving as lead counsel for several generic manufacturers since 1999, in cases involving a number of small molecules. more...


Best Regards.
Marketing.

BioPratice.com
Follow US on