RECORDED SEMINARS
Recorded Seminar
Requirements for Launching New Products : USA & Internationally &
Biologics in a World with Biosimilars
timelapse Full Day (09:00 AM - 05:00 PM) with 15-30 mins of Q and A
Note:
Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared
Speaker/Presenter
Short Abstract
This seminar is designed for biotechnology, pharmaceutical and medical device business executives, investment bankers, advisors and their clients, and others with interest how to meet new requirements to demonstrate comparative effectiveness and real world medicine and medical device impact for health care payers.
The presentation will also 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.
Program Agenda
Morning Session (10:00 AM - 02:00 PM EDT)
Requirements for Launching New Products : US & Internationally
This workshop will teach you about:
Afternoon Session (03:00 PM - 05:00 PM EDT)
Biologics in a World with Biosimilars
This presentation will cover the following:
Requirements for Launching New Products : US & Internationally
This workshop will teach you about:
- Requirements by health care payers for Comparative Effectiveness Evaluations and Real World Data of Health Care Product Impact
- Comparative Effectiveness Evaluations – Definition, methods, limitations and practical strategies for completion to ensure accuracy.
- Real World Studies: Design, approval, conduct and analysis
- Case studies of Comparative Effectiveness Evaluations and Real World Studies that helped to gain product approval and reimbursement.
Afternoon Session (03:00 PM - 05:00 PM EDT)
Biologics in a World with Biosimilars
This presentation will cover the following:
- A global overview of possibility of competition in the biologics markets through the availability of biosimilars.
- Review of FDA progress, including the Agency’s progress with their unique authority on being able to designate a biosimilar as interchangeable with its reference product
- Issues that have been raised in the context of biosimilars - extrapolation, naming, use of foreign reference product in clinical studies, and the relevance of state laws will also be discussed.
Registration Information
- Registration Fee : USD $299
- For assistance on registration, please send an email to
marketing@biopractice.com or
Please call: Ph - 1-646-216-8860