Drugs and medical devices are a hotbed for innovation, and regulatory strategy is inextricably intertwined with other business and legal objectives, such as intellectual property (IP) protection, risk management, and competitive positioning.
During this session, participants will learn about:
- the interplay between IP and regulatory affairs (e.g., regulatory exclusivities and integrating regulatory, IP, and post-market surveillance (PMS) data intelligence into product innovation)
- strategies for aligning development, regulatory, and IP milestones with the product lifecycle and exchanging information across organizational disciplines
- pragmatic tools which can be leveraged to identify competitive movements and technological developments (Orange/Purple Book, patent filings, PMS tools)
- best practices for using these tools as inputs to foster pre-and post-market regulatory strategy, post-market surveillance, and accelerated product innovation.
Audience Learning Level
Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.
Location
Buchanan Ingersoll & Rooney (Philadelphia Office)
2 Liberty Place, 50 S 16th St
Suite 3200
Philadelphia, PA 19102
**Light refreshments provided
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
Alexandra Smythe
Joshua L. Cohen
Barbara Binzak-Blumenfeld
Sponsor
