Advisory Board

Kazuko Aoyagi

Director for International Business Development and Regulatory Services for Celerion, a large, international CRO (formerly MDS Pharama)

Martha A. Brumfield, Ph.D.

Dr. Brumfield is the Director for International Programs at the Critical Path Institute and is the founder of Martha Brumfield Associates, recently serving as Senior Vice President and Head, Worldwide Regulatory Affairs and Quality Assurance at Pfizer Inc.

Joseph H Carabello

CEO of CPR Communication, he was responsible for the start up and marketing programs of several HMOs including Oxford Health Plans and Health Care Plan of New Jersey. Mr. Carabello also served as Vice President of Olsten Health Care.

Laura S. Carabello

Founder & COO of CPR Communications, and Publisher of Medical Travel Today, she is an international health care journalist and marketing strategist who regularly speaks at global summits on healthcare and medical travel marketing.

Peter Honig, MD, MPH

SVP and Global Head, Regulatory Affairs, AstraZeneca. Previously Peter served with Merck,where he was responsible for Global Regulatory Affairs and Operations. Prior to joining Merck, Dr. Honig founded and was the first Director of the Office of DrugSafety in the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER).

Joseph P. McMenamin, MD, JD

Partner at McGuireWood law firm, Mr. McMenamin is Board-certified in Legal Medicine and a Fellow of the College of Legal Medicine. Mr. McMenamin's primary focus is on the defense of pharmaceutical products, medical devices, vaccines, and foods, but he also advises clients in those industries on managing risks and on regulatory issues such as those pertinent to informed consent, clinical trials, industry-provider relationships, pharmaceutical marketing, and corporate communications.

Mary Jane Nehring, Ph.D.

Head of Asia-Pacific Regulatory Affairs at Bausch and Lomb, and former Executive Director, Global Regulatory Affairs, at Schering-Plough where she led regulatory strategies for Asia Pacific, Latin America, Middle East, Africa, and Eastern Europe.

Mark S. Paxton, MS, JD

Mark is an Executive Vice President at Humphrey Regulatory Consulting Inc. where he serves clients using his extensive background in international regulatory practices. Recently, Mark served as the Associate Vice-President for International Regulatory Affairs at Pharmaceutical Research and Manufacturers of America (PhRMA).

Colin Vickers

VP, International Regulatory Affairs at Eisai, former Head of International Regulatory Affairs for Pfizer where he was responsible for Asia, Latin America, Middle East, Africa and non-EU Europe. Previous to Pfizer, Colin held similar positions at GlaxoWellcome and the Wellcome Foundation.

Serving on the RHI Advisory Board

  • All Group/Institutional Members are eligible to serve on the Advisory Board by their most senior scientific or regulatory officers or their delegates.
  • Chairs of GCs will serve on the Advisory Board during their terms.
  • Serving at the discretion of RHI members, at-large Advisory Board members will be designated by the Board of Directors. At-large Advisory Board Members will be qualified by experience and expertise in international regulatory matters.

RHI Advisory Board - Proceedings

  • The proceedings of the Advisory Board will be formal. All decisions taken by the Advisory Board will be subject to majority vote, with at least a quorum present, either in person or via teleconference.
  • The proceedings will be transparent, and actionable decisions documented. Space permitting, GC members will be invited to attend and observe, with an opportunity to express views to be determined by the Advisory Board.

RHI Advisory Board - Responsibilities

  • The RHI Advisory Board shall, by majority vote and in consultation with the chief executive of RHI, approve RHI committees to develop Educational and Advocacy Plans (EAPs) on behalf of RHI.
  • Upon recommendation of the various RHI GCs to adopt an EAP, the RHI Advisory Board, in consultation with RHI's chief executive, shall discuss a submitted EAP and then vote on whether to accept it. If not accepted, the EAP will be remanded to the submitting GC for further consideration of specific objections raised by the Advisory Board.

Educational and Advocacy Plans

RHI presents to industry and other stakeholders a new way of addressing regulatory needs and concerns. Recognizing that effective regulatory advocacy cannot occur without educating all stakeholders, it is the development and implementation of the Educational and Advocacy Plans (EAPs) that are central to the value that RHI brings to its members, to regulatory authorities, and ultimately, to patients.

RHI shall provide each GC with guidelines on development of EAPs. At a minimum, EAPs must include the recommendation of the GC, identify the regulatory authorities to whom that recommendation will be directed with a reasonable basis thereof, and how to present that recommendation