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Tuesday, June 26 • 4:15pm - 5:30pm
#286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-614-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000225; RN 1.25

This forum will include multiple regulatory project management staff from the FDA who will give a brief presentation of their roles and responsibilities and describe what their role is during the drug development process. Each project management group has a very unique role during the drug development process and this will be presented during the forum. During the panel discussion each group will explain how they communicate and collaborate amongst each other and keep each other informed. After the presentations, a representative from each group will be a part of the panel discussion to answer questions from the audience members.

Learning Objectives

Describe the different offices throughout CDER which have their own regulatory project management staff; Explain the appropriate regulatory project manager to contact about for specific issues relevant to your product application - IND, NDA, BLA, combination product; Design best practices for managing interactions with FDA.

Chair

Wayne Amchin

Speaker

Panelist
Renmeet Grewal

Panelist
Sean K Bradley

Panelist
Hamet M. Toure, PharmD, MPH


Speakers
avatar for Wayne Amchin

Wayne Amchin

Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobile... Read More →
SB

Sean Bradley

Chief Project Manager, Safety Regulatory Management Staff, OSE, CDER, FDA
CDR Sean Bradley is a Chief of the Safety Regulatory Project Management Staff in the Office of Surveillance and Epidemiology; overseeing the coordination of OSE pre- and post-market safety reviews for: Oncology/Hematology, Pulmonary/Allery, and Metabolic/Endocrine therapeutic designations... Read More →
avatar for Renmeet Grewal

Renmeet Grewal

Division Director, Office of Regulatory Operations (DRO-II), OND, CDER, FDA, United States
Renmeet is a Division Director in the Office of Regulatory Operations within the Center of Drug Evaluation and Research in the Office of New Drugs. She develops policies and procedures and provides leadership for regulatory activities of the review and evaluation of New Drug applications... Read More →
HT

Hamet Toure

Program Management, OPRO, OPQ, CDER, FDA
Commander Hamet Touré is an officer in the Public Health Service. He worked as a project manager in the OND Division of Neurology Products for 6 years. He served as the acting OPQ/OPRO Branch 1 Chief for the last two years. Prior to joining FDA, CDR Touré worked within the pharmacy... Read More →

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjMgt-StrategicPlanning, Forum