About IPEC-Americas

IPEC-Americas Committees & Working Groups

IPEC-Americas Standing Committees, Subcommittees & Technical Working Groups (click the links below to read about each committee)

Volunteers needed! 
There is currently a vice chair vacancy for the Safety committee. If you are a member and have an interest in volunteering to assist, please contact our office at (571) 814-3449. Vice chair responsibilities include taking meeting minutes at meetings or telecons.

Compendial Review/Harmonization Committee
Excipient Qualification Committee
Good Manufacturing Practices Committee
Quality by Design (QbD) Product Development Committee
Regulatory Affairs Committee
Safety Committee

Quick Links:
IPEC-Americas Organization Chart
2017 meeting schedule
Accomplishments


Compendial Review/Harmonization Committee
Next Meeting Date & Time: 2/28/17 (8:00AM-12:00PM) 
Location IPEC-Americas HQ 3rd floor.

Responsible for harmonization of excipient monographs between the United States Pharmacopeia, the European Pharmacopeia and the Japan Pharmacopeia.  The Harmonization Committee may work in conjunction with other regional Pharmaceutical Excipients Councils to achieve this goal.  The Committee shall consult with the Chair on matters related to the IPEC Federation.  Technical working groups may communicate directly with their regional Excipient Council equivalents.

Chair: Phyllis Walsh
Associate Director, Merck & Company, Inc

Vice Chair: George Collins
Vice President, Vanderbilt Mineral Co.


Regulatory Affairs Committee
Next Meeting Date & Time: 2/28/17 (1:00-5:00 PM) 
Location IPEC-Americas HQ 3rd floor.

Responsible for assessing excipient related regulations and regulatory guidelines that are promulgated by FDA or international regulatory agencies and coordinating the development of IPEC positions on these issues.  The Regulatory Affairs Committee also develops IPEC Americas guidelines to support excipient use and development in the United States with consideration to international drug registration processes and monitors associated regulations in the food additive arena which may have implications on the use of pharmaceutical and dietary supplement excipients.

Chair: Meera Raghuram
Manager, Global Regulatory Affairs & Strategies, Lubrizol Advanced Materials, Inc.

Vice Chair: Katherine L. Ulman
KLU Consulting


Good Manufacturing Practices Committee
Next Meeting Date & Time: 3/1/17 (8:00AM-12:00 PM) 
Location IPEC-Americas HQ, 3rd floor.

Responsible for developing and maintaining good manufacturing practices and related guidelines.

Chair: Paul Smutz
Global Compliance Manager, Henkel Corporation

Vice Chair: April Hernandez
Regulatory Affairs Specialist, FMC Corporation


Excipient Qualification Committee
Next Meeting Date & Time: 3/1/17 (8:00AM-12:00 PM) 
Location IPEC-Americas HQ, 3rd floor.

Provides guidance to excipient manufacturers on the development of an excipient grade material and its specifications; guidance on how users select and assess excipients for use in their formulations; and guidance on elements included in the necessary excipient maker-user negotiating process leading to quality requirement agreements between the parties.

Chair: Bretta Lichtenhan
Regulatory Affairs Manager, EMD Millipore Corporation

Vice Chair: Heather Sturtevant
Manager, Technical Operations, McNeil Consumer Healthcare (J&J)


Safety Committee
Next Meeting Date & Time: 03/1/17 (1:00-3:00 PM) 
Location IPEC-Americas HQ 3rd floor.

Responsible for providing safety guidance requested by the Board of Trustees, the Executive Committee, or by any Standing Committee.

Chair: Lisa W. Webber
Director – SQM/Procurement Process Deployment, Johnson & Johnson


Quality by Design (QbD) Product Development Committee
Next Meeting Date & Time: 3/2/17 (8:00AM-12:00 PM) 
Location IPEC-Americas HQ 3rd floor.

Composed of pharmaceutical formulators, excipient scientists, and other experts from industry and academia. They work together to establish standardized decision-tree processes to better understand the link between excipient properties and functionality in different formulations and manufacturing systems.  The QbD Committee also develops guidelines to assist in product development.

Chair: Brian Carlin, Ph.D.
Director, Open Innovation
FMC BioPolymer

Vice Chair: David R. Schoneker, MS
Director of Global Regulatory Affairs, Colorcon

Working Group
Excipient Composition


USP Liaison
Responsible for USP proposals and to provide the USP with clear statements of excipient industry positions on matters that can affect excipient development and use.

Designated Representative: Priscilla Zawislak
Chair, IPEC-Americas