Categorized | Opinion Editorial, QbD News

Can Regulatory Harmonization Be More Effective, and Equitable?

    Can Regulatory Harmonization Be More Effective, and Equitable?

    By Paul Thomas, Senior Editor

    This month, the not-for-profit Regulatory Harmonization Institute was launched, with the mission of being a regulatory body to better represent the interests of emerging countries and “non-regulatory stakeholders.” (Read RHI’s press release here.) Founding members include BIO, the Generic Pharmaceutical Association (GPhA), and other notable global organizations, as well as representatives of AstraZeneca, Bausch & Lomb, and other major drug and device manufacturers. (See below for profiles of the organization’s leadership.)

    The new organization is rooted in the belief that global harmonization efforts to date, says RHI president Dean Erhardt, have failed to:

    • Include significant and meaningful input from non-regulators (especially industry)
    • Adequately represent the interests of emerging nations
    • Better balance drug regulation with business interests
    • Successfully build global “regulatory capacity”

    These are strong assertions. To find out more, we sought out Erhardt, who is also principal of D2 Pharma Consulting, LLC:

    PharmaQbD: What’s the impetus for RHI? What is it going to do that other bodies (namely, ICH) are not doing?

    D.E.: RHI differs from the ICH efforts in variety of ways—however, most notably:
    a. The ICH efforts are very regionally based in that they are focused on the EU, the U.S. and Japan, effectively excluding other countries, particularly emerging markets;
    b. RHI is working to address key issues that are outside of the scope of ICH—namely, issues such as: a) administrative issues; b) compliance; and c) global consistencies around manufacturing implementation.

    Further, while various organizations engage in regulatory capacity building with some success, results are extremely limited because:

    a. industry (multi-national corporations nor local companies) is neither a participant nor a target of those efforts. RHI is working to include industry, particularly in the emerging markets;
    b. there is a complete failure by regulatory authorities and other regulatory stakeholders to properly educate non-regulatory stakeholders; and
    c. as a consequence of this lack of education, poorly understood regulatory practices are made subservient to other priorities by these non-regulatory stakeholders.

    RHI is focused on addressing each of the above factors by enabling strategic capacity building among BOTH regulatory authorities and regulated industries. This capacity building is effectively acting as the vehicle to leverage regulatory harmonization efforts already underway, and empower them through dialog, training, and external communications to non-regulatory stakeholders.

    In doing so, RHI is focused on the efforts that are driven by the best available scientific underpinnings, rather that directing efforts toward mitigation of any nation’s specific rules or regulations that, when viewed from a global perspective, seem redundant or unnecessary, but in fact are established under very different economic, knowledge and other constraints affecting any single nation.

    PharmaQbD: What are the various ways that drug manufacturers can work with and use the institute’s services?

    D.E.: RHI is a membership organization that is working with manufacturers across multiple fronts to assist in the educational process related to regulatory issues. RHI is currently working with multiple international companies to assist in their understanding of the U.S. market. In addition, RHI is working with working with various government agencies to support educational programs for companies looking to expand from local to multi-national status. Specifically, RHI has provided educational programs for Japanese and Korean entities.

    PharmaQbD: Part of your mission is to “identify divergent regulatory practices.” Once identified, will RHI seek to influence regulators to bring the divergent practices more in line with each other?

    D.E.: Simplistically, yes. RHI will work to educate industry on both the “identified divergent regulatory practices” and solicit feedback from industry, going beyond just the regulatory to create practices that are both sound from a regulatory perspective but also sound business policy.

    PharmaQbD: Finally, does RHI plan to be more behind-the-scenes in working with regulators and industry, or will it be out front seeking to shape public opinions and media perceptions?

    D.E.: RHI will be working on both sides of this issue, working with regulators and industry to create a communication link that facilitates and expedites key issues. In addition, RHI will be working in conjunction with various regulatory and industry associations to address regulatory issues and to help shape the public dialogue.

    More about RHI and Its Founders:
    RHI is a non-profit organization directed solely at education regarding regulatory harmonization.  RHI is incorporated as a not-for-profit under Delaware law.  RHI is focused on providing an open and transparent venue for public and private stakeholders to identify divergent regulatory practices that meaningfully affect the availability of high quality, safe and efficacious medical products to patients across the globe, and to develop and sustain educational and other work plans that will assist in harmonizing those practices.

    Current Leadership Team include:

    Dean Erhardt, MBA – President
    Dean Erhardt was elected by the Advisory Board to the Presidency of RHI effective September 26th 2011.  Dean Erhardt offers over 25 years of strategic marketing and management experience across both the consumer product and pharmaceutical arenas.  Mr. Erhardt has assisted over 100 pharmaceutical companies over the past 7 years. Prior to consulting, Mr. Erhardt’ career spanned several Fortune 500 organizations including Express Scripts, Cardinal Health and U.S. Healthcare.

    Joseph H Carabello – Vice President, Founder
    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 – Secretary, Founder
    Founder & COO of CPR Communications, and Publisher of Medical Travel Today, she is an international health care journalist and marketing strategist who is a regularly speaker at global summits on healthcare and medical travel marketing.

    Kazuko Aoyagi – Board Member
    Director for International Business Development and Regulatory Services for Celerion, a large, international CRO (formerly MDS Pharama)

    Martha A. Brumfield, Ph.D. – Board Member
    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.

    Peter Honig, MD, MPH – Advisory Board
    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 – Advisory Board
    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. – Advisory Board
    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.

    Colin Vickers – Advisory Board
    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.

     

    image courtesy Nasa.gov

    Related posts:

    1. The Regulatory Walls Are Falling Down
      Optimistic opinions on the state of regulatory harmonization, courtesy of Sparta Systems’ K.R. Karu....
    2. FDA Releases Strategic Plan for Advancement of Regulatory Science
      The plan covers various Science Priority Areas, including improving product manufacturing and quality through the furthering of continuous processes, analytical...
    3. Drug Manufacturing: Still Waiting for the Sea Change?
      Pharmaceutical Manufacturing's April cover story asks the question, have we made real and tangible progress in the past decade?...
    4. White Paper: Effective ICH Q8 Pharmaceutical Development Reports
      A complete PDR is essential to provide a comprehensive understanding of the product and process for the FDA application reviewers...
    5. Snippets from AIChE: Navigating QbD’s Shades of Gray
      A Q&A session focused on subtleties of QbD and QbD-based regulatory filings, suggesting that not everything always needs to be...

    Leave a Reply

    You must be logged in to post a comment.