International Seminar on Biologics in a World with BIosimilars

TUESDAY, 30th April | 03:00 PM - 05:00 PM EDT
VENUE : DAVIO'S, 111 South 17th Street, Philadelphia-PA, 19103

Short Abstract:

The presentation will provide a global overview of what has, as well as what hasn’t, changed with the possibility of competition in the biologics markets through the availability of biosimilars.

While Europe has led with biosimilars, and to some extent the highly regulated markets have followed with similar approaches, the emerging markets have found other ways to serve their needs for access and affordability to these remarkable biologic medicines. And yet the US, while 50% of the global market for biologics has yet to fully implement the biosimilars pathway for which the FDA was granted statutory authority in early 2010.

Progress at the FDA will be reviewed, including the Agency’s progress with their unique authority on being able to designate a biosimilar as interchangeable with its reference product. Other issues that have been raised in the context of biosimilars, such as extrapolation, naming, use of foreign reference product in clinical studies, and the relevance of state laws will also be discussed

Speaker Profile :

Gillian Woollett, MA, DPhil, Vice President, leads the FDA Practice within Avalere's Center on Evidence-Based Medicine. She provides the “prequel” of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate CMS and health care policy/business world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate CMS and health care policy/business world.

Who Should Attend:

CSOs, VPs, Directors, Heads, Managers working within:

  • Pharmaceuticals/Biotech R&D
  • Regulatory Compliance
  • Preclinical Development
  • New Product Development
  • Quality Assurance/ Quality Control
  • Pharmacovigilance
  • Drug Safety & Risk Management
  • Process Control and Analytical Technologies
  • Lab Supervisors and Managers
  • Academic Research Laboratory
  • Regulatory Affairs
  • Drug Development/Pharmaceutical Development
  • Labeling Of Medicine

Registration Information:

To register online, please visit : http://www.biopractice.com/bioevents/biologics_biosimilar.html

Registration Fees : USD $499, *Discounts on Group Registrations Available

For discount on Group Bookings, please send an email to :
marketing@biopractice.com or Call Us at 1-646-216-8860