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Live Webinar Successful FDA Meeting Preparation and Conduct

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Website https://worldcomplianceseminars.com/webinardetails/385 | Edit Freely

Category

Deadline: April 25, 2018 | Date: April 25, 2018

Venue/Country: Online, U.S.A

Updated: 2018-04-16 21:26:40 (GMT+9)

Call For Papers - CFP

Live Webinar Successful FDA Meeting Preparation and Conduct

Date: 02:30 PM EDT | 11:30 AM PDT | 01:30 PM CDT Duration 90 Minutes

Description

The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, clinical hold, or for breakthrough therapy topics).

Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.

Why You should Attend The Session

The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tend to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, clinical hold, or for breakthrough therapy topics).

Rehearsal, post-meeting follow-up, and documenting nonformal FDA interactions will also be discussed in detail.

Areas Covered

• Standard FDA Meeting Types and Timing

• General Qualifying Requirements

• Preparing the Meeting Request

• Preparing the Briefing Document

• Rehearsing for the Meeting

• Conduct of the Meeting

• Post-Meeting follow up

• Non-typical FDA meetings

• Preparation for non-typical meetings

• Documenting Informal meetings and correspondence

• Reference to meetings during future submissions

Who will Benefit

• Regulatory Affairs Departments

• Quality Departments

• Compliance Departments

• Program Management Teams

• Project Management Teams

• Manufacturing Departments

• Everyone who may contribute to or participate in an FDA

meeting

Speaker Profile

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001).

Price: $179 One Dial-in One Attendee | Corporate Live Recorded $279 One Dial In - Max 10 attendees |Group $695 Multiple locations upto 5 dial in | Recorded $249


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.