Sponsored Webcast: How to Facilitate Regulatory Meetings

1.5
RAC Credits
Wednesday, 01 May 2019 (12:00 PM) - Wednesday, 01 May 2019 (1:30 PM)

Sponsored by: 

The role of facilitator often falls to regulatory on development teams, a default decision which is both challenging and coherent. It is difficult to act as both a mediator and stakeholder, keeping complex teams focused and interactions running efficiently. But regulatory professionals can make expert facilitators, when prepared with mediation skills.

This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation – from active listening to on-the-spot decision making, from managing personality types to those with opposing beliefs. Learn to effectively facilitate teams as they prepare for, conduct, and debrief important meetings.

Learning Level:

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

Learning Objectives

After attending this webcast, you will be able to: 

  • Implement facilitation techniques vital to effective preparation for, conduct of, and debrief after FDA meetings
  • Raise the regulatory voice at internal and external meetings
  • Keep meetings focused and attendees on task

 

Who Should Attend?

  • Regulatory professionals that regularly facilitate meetings
  • Executives that wished internal/external meetings ran more efficiently
  • Team members or leaders in need of a mediator or facilitator

 

Speakers

Frank Carillo, CEO, ECG

Frank Carillo has worked with clients who present new drug applications to FDA Advisory Committee meetings for approval and commercial release. Under his direction, ECG has achieved an impressive record of success. They have supported over 170 FDA AdComms, including numerous first-in-class approvals across a wide variety of therapeutic areas, and many MAA approvals (including Oral Explanations and Scientific Advisory Groups) with the EMA. Carillo and his team have the deep experience and knowledge to get drugs, devices, biologics, and vaccines approved. He originally learned facilitation principles and techniques at the Wharton School of Business.  Throughout his career, Carillo’s demonstrated how communication strategy empowers people to support internal and external teams, objectives, and scientific advocacy from a position of regulatory strength.

Lisa Malandro, MBA, vice president of regulatory affairs North America, DBV Technologies

During a career that spans more than 15 years, Lisa Malandro has learned the value of good facilitation skills. With experience from FDA/CDER, large pharma, and mid-size and start-up biotech, she is well-suited to provide insights on how best to lead teams to successful discussions internally and with Health Authorities including FDA, EMA, and PMDA. Malandro holds an MBA with a concentration in finance from Johns Hopkins University. She is passionate about mentoring the next generation of regulatory affairs professionals.


Need Assistance? Contact the RAPS Solutions Center at +1 301 770 2920, ext. 200.

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