Conducting regulatory reviews of novel therapies in a timely manner is essential to improve public health concerns and ensure medical needs are met. There are regulatory mechanisms in place worldwide to accelerate the delivery of treatments for patients with serious diseases or unmet medical needs.
Many regulatory authorities throughout the world have implemented pathways that aim to expedite the submission or the review of products that cater to these medical needs. Understanding how to utilize expedited regulatory paths like Breakthrough Therapy Designation, PRIME, and Sakigake Designation is imperative to make an informed decision about the best ways to accelerate drug development.
These regulatory options are available to ensure regulatory bodies allocated the resources to review and approve therapies as soon as the benefits justify any risks. Our 2nd
Innovative Regulatory Pathways will serve as a platform to discuss and compare the current regulatory pathways that allow for earlier attention to drugs that have promise in treating serious or life-threatening conditions.
Learning Objectives
- Navigate the global regulatory landscape and effectively anticipate the future accelerated options
- Discuss the implications of breakthrough therapy designation, PRIME, and Sakigake Designation on development pipelines
- Network with worldwide leading regulatory experts who have experience leveraging the increased consideration that comes with utilizing an expedited development pathway
- Discuss regulatory strategies to optimize product development timelines
- Learn about best practices to liaise with the FDA, EMA, and PDMA about expedited regulatory approvals
Who Should Attend
This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies and advocacy groups with responsibilities in the following areas:
- Regulatory Affairs/Strategy/Operations
- Business Development/Strategy
- Clinical Operations/Development/Affairs
- Product Development
- R&D/Drug Development
- Patient Advocacy
- HEOR and Outcomes Research
- Strategic Planning
- Competitive Intelligence
- Oncology Program Management
- Rare Disease/Orphan Program Management
- Pipeline/Portfolio Management
- Pharmacovigilance
- Medical Information/Affairs
This conference is also of interest to:
- Regulatory Advisors/Service Providers/Consultants
- Clinical/Contract Research Organizations
- Drug Development Service Providers
- Law Firms
- Preclinical/Analytical Research Organizations
- Strategic/Management Consultants
Speakers
- Mike Fahmy, Senior Director Global Regulatory Affairs, OTSUKA
- Brian E. Harvey, M.D., PH.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE
- Camille Jackson, Associate Vice President, Science and Regulatory Advocacy, PHRMA
- Lawrence Liberti, Executive Director, CENTER FOR INNOVATION IN REGULATORY SCIENCE
- Usha Ramesh, Executive Director, CMC Regulatory Affairs, PHARMACYCLICS
- William K. Sietsema, Ph.D., Executive Director, Global Regulatory Affairs, CALADRIUS BIOSCIENCES
- Mark Stewart, Senior Science Policy Analyst, FRIENDS OF CANCER RESEARCH
- Ronald Szumigala, Director - RAI HQ - Biologics, Oncology, MERCK
- Dr. Long Wang, Director, Global Regulatory Team Leader, Vaccines/Infectious Disease, MERCK
- Martine Zimmermann, Senior Vice President, Global Regulatory Affairs, ALEXION PHARMACEUTICALS, INC.
Please fill in your name and email to receive the Summit Agenda of this event.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Venue
Sheraton Pentagon City900 S. Orme St.
Arlington, VA 22204
Discover something new at the recently renovated Sheraton Pentagon City Hotel. From new carpeting and totally updated guest rooms to an all-new lobby, we're evolving with your comfort in mind. Stay connected with our lobby's new ''connection destination,'' the Link@Sheraton experienced with Microsoft, which offers a secure and fun area to work or just hang out. Or, retreat to our chic and all-new guest rooms, newly outfitted with our signature Sheraton Sweet Sleeper Bed and flat-screen TV.
With the Reagan National Airport; Metro Rail Station; downtown Washington, DC; and the Pentagon all just minutes away, the heart of the nation is at your fingertips. Through arranging discounted overnight accommodations, transportation, receptions and other services, our trained team of professionals can help remove some of the stress surrounding the planning of a memorial at Arlington National Cemetery or any other event in the area.
To make reservations, please call 1-800-325-3535 and request the negotiated rate for ExL's January Meetings. To make reservations online
Click HereThe group rate is available until January 7, 2018. Please book your room early, as rooms available at this rate are limited.
