Click HERE to register for a LIVE presentation from industry expert Dr. Mukesh Kumar on How to “Win” FDA’s support for Your Clinical Development Program.
All development programs are not alike. What differentiates a smart development program from others is that such programs not only are built on a deep understanding of the applicable regulations and guidance documents but also a thorough awareness of the changing circumstances and expectations. Meetings with the FDA to discuss the development program is just one piece of this effort to build a rapport with the regulators. Carefully crafted experiments involving dedicated subject matter experts, clinical trial programs attuned with the patient perspectives, timely pursuit of regulatory designations, adequate resource allocation to reduce risks, and constant involvement of FDA in the sponsor decision process can contribute to creating an environment for strong FDA support for a given program. FDA must consider not just the technical aspects of given development plan but also public health needs, patient opinions, policy, and scientific merits to lend its support. The regulatory strategy should be integral and dynamic.
This seminar will discuss ways developers can take a wholistic approaches to create a program that can win FDA’s support. The speaker will discuss how companies can develop competitive regulatory programs. The seminar will highlight key strategies to maintain high quality proactive regulatory intelligence, dos and don’ts, common areas of concern, and trouble-shooting practices. The pros and cons of the “follow-the-leader” approach and investing in new ways of working will be discussed. These innovative business approaches are also useful for established organizations to create lean, adaptive regulatory affairs teams.
Click HERE to register.