SAN DIEGO, October 31, 2023 (Newswire.com) - Pace® Life Sciences, a leading full-service pharmaceutical contract research and manufacturing organization, announces an exclusive half-day event, Navigating the Regulatory Roadmap: Insights and Strategies, set to take place on Nov. 16, 2023, in downtown San Diego.
Pace® has assembled an exceptional lineup of experts to provide those involved in regulatory affairs and drug and therapy development invaluable insights and strategies for navigating the ever-evolving pharmaceutical landscape. "We are excited about this workshop and the opportunity to share insights on the FDA's role in early-phase drug development,” remarked Will Wittbold, head of the Pace® Life Sciences San Diego laboratory. “Our speakers and panelists aim to equip attendees with the knowledge to navigate the regulatory landscape effectively, highlighting both opportunities and potential pitfalls. This will be a wonderful interactive learning experience for all present."
Session topics and presenters of Navigating the Regulatory Roadmap: Insights and Strategies include:
The Investigational New Drug Application. Paula Garcia Calavia, Ph.D., will provide a comprehensive overview of this critical stage in drug development.
eCTD-Compliant Publishing and Submissions. Antony Kaprielian will delve into the latest standards and best practices for electronic submissions.
Orphan Designations in the US and the EU. Darius Devlin, Ph.D., will shed light on these important lesser-known designations.
Expedited Review Programs. Isaiah Manoogian, PharmD, will discuss the FDA’s Fast Track Designation and Breakthrough Therapy Designation.
Regulatory Concerns in Early-Phase Drug Product CMC Development. Will Wittbold, head of Pace® Life Sciences, San Diego, will host panel of life sciences scientists discussing real-life regulatory insights.
The workshop is designed to empower pharmaceutical professionals with the latest knowledge and insights to navigate regulatory challenges and uncover opportunities in the pharmaceutical industry to gain a competitive edge.
"I'm looking forward to connecting with industry professionals and addressing the FDA's regulatory challenges head-on,” said Angela Wutz, Senior Director of Consulting Services at Pace® Life Sciences. “Our team at Pace® is dedicated to providing solutions and strategies for overcoming these hurdles. This event is a perfect platform to share our expertise and engage with others who share our commitment to advancing life-changing pharmaceuticals to market."
Attendance is complimentary, but seats are limited. Those interested in attending may register here and use the coupon code PACE_VIP at checkout to waive the registration fee. For more information about the event, contact workshop organizer Matthew Duffy at [email protected].
Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.
About Pace Life Sciences:
Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of GMP analytical testing laboratories and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. More at pacelifesciences.com.Contact Information:
Tunheim Public Relations
Original Source: Pace Life Sciences Presents Workshop Designed to Navigate the Complex Regulatory Terrain of Early-Phase Drug Development