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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.