Natural Health Products Program Advisory Committee and Working Groups Member Biography and Summary of Affiliations and Interests Declaration - 2009-2010

The following biographies and Summaries of Affiliations and Interests Declarations (SAID) present summarized information related to the expertise and experience offered by each member of the Natural Health Products Program Advisory Committee (NHP-PAC) and a summary of their affiliations and interests. As outlined in the Terms of Reference of the NHP-PAC, prior to participation as member of the NHP-PAC, all Active Members must receive "enhanced reliability" security clearance, and complete and sign a declaration of affiliations and interests and a confidentiality agreement.

• Committee
• Working Group #1 - Standards of Evidence for Non-Traditional Natural Health Products
• Working Group #2 - Product Testing Requirements Connected to Good Manufacturing Practice Requirements for Natural Health Products
• Working Group #3 - Compliance and Enforcement for Natural Health Products
• Health Products and Food Branch Advisory Body Member Affiliations and Interests Declaration

Committee

Dr. Anuradha Bose (Ph.D.) is Head of the Ottawa office of Option consommateurs, a not-for-profit organization dedicated to defending and promoting consumers' rights in fields as diverse as natural health and other products, food and financial services. She holds a Ph.D. in Development Administration from the University of Birmingham UK with a specialization in Economic Anthropology and Behavioural Economics. She has had considerable involvement with the not-for-profit sector both as staff and Board member in Canada, Switzerland and Sri Lanka and she was Head of the Department of Public Administration, of KIMEP, the former Presidential Institute of the Republic of Kazakhstan under the Know-How Fund of the Foreign and Commonwealth Office of Her Majesty's Government of Great Britain. She has had a life-long interest in Ayurveda, alternative therapies and homeopathy and their regulation.

Mr. Carl Carter has 29 years of regulatory, policy and management expertise in the consumer product and trade association sectors. He is a former member of Health Canada's Natural Health Products Directorate Management Advisory Committee and he Co-Chaired the joint Health Canada/Environment Canada Environmental Assessment Working Group. He has extensive experience in working with broad stakeholder committees, as well as numerous trade association committees, including acting as former Chair and Board member of a national consumer products trade association. He has an Honours B.Sc. (Chemistry & Biology) from Wilfrid Laurier University and is a Certified Association Executive.

Mr. Carter has extensive Canadian and international experience with the regulation and compliance of consumer products, including natural health products, drugs, cosmetics and foods. He has expert knowledge of the Food and Drugs Act and its regulations, the Canadian Environmental Protection Act, Legislative Renewal, Cost Recovery, Packaging Waste and numerous other health and environmental legislation and regulations. He is currently Director of Regulatory Affairs with the Canadian Health Food Association.

SAID - Mr. Carter is a full time employee of the Canadian Health Food Association (CHFA), a national industry trade association which may have an interest in the mandate and work of the NHP-PAC. As part of his role and function with the CHFA, Mr. Carter may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC and may make public statements on issues of relevance to the NHP-PAC mandate.

Mr. Joseph Chan is a full-time employee of Bayer Inc., a regulated industry stakeholder which is a member of the Canadian Health Food Association, a national industry trade association which may have an interest in the mandate of the NHP-PAC. Mr. Chan is also employed part-time as a community pharmacist where he recommends and sells NHPs to patients in pharmacies.

Mr. Lawrence Cheng is a founding director and current Vice President for Regulatory Affairs of the Chamber of Chinese Herbal Medicine of Canada (CCHMC). He also helped found Sun Ming Hong (Canada) Ltd., in 1983, an importer, distributor and retailer of traditional Chinese medicine as well as one of the most active exporters of Canadian ginseng. His family has a long history in the traditional Chinese medicine industry, dating from the mid-1800s.

SAID - Mr. Cheng holds shares in and receives remuneration from Sun Ming Hong (Canada) Inc. As volunteer member of the CCHMC, an industry trade association that may have an interest in the mandate and work of the NHP-PAC, he may receive reimbursement for conference costs and member dues, may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC and may make public statements on issues of relevance to the NHP-PAC mandate. He also participates, as part of his role and function with the CCHMC, in meetings with Health Canada on issues of relevance to the traditional Chinese medicine industry.

Ms. Suzanne Gaudette graduated from the Université du Québec à Montréal in 1989 with a Bachelor's degree in Biochemistry and is a member of l'Ordre des Chimistes du Québec. She has been working in the natural health products industry since obtaining her degree. For the past eight years, she has been employed at Heel Canada Inc., a homeopathic products company, in Montreal with head offices in Germany, as the person responsible for Quality Assurance, Quality Control and Regulatory Affairs. She chairs the Technical Committee of the Canadian Homeopathic Pharmaceuticals Association (CHPA). As such, she has participated in working groups and meetings towards advancing legislation and guidance for homeopathic products and has had the opportunity to meet people within the homeopathic products and NHP community in general and also Health Canada representatives to discuss items of interest to CHPA members.

Ms. Gaudette is a school commissioner and has been actively implicated in the Quebec public school system since 1996. She believes that education is the key to the success of our collective future.

SAID - As a full-time employee of Heel Canada Ind., a regulated industry stakeholder and as a volunteer member of the CHPA, a national industry trade association that may have an interest in the mandate and work of the NHP-PAC, Ms. Gaudette may receive reimbursement for conference costs and member dues, may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC and may make public statements on issues of relevance to the NHP-PAC mandate.

Ms. Barbra J Johnston has been, since 1991, President of Nature's Formulae Health Products Ltd., a manufacturer of natural and herbal based products with Certified Organic licensing located in Kelowna, British Columbia (BC). The company has been nominated for the BDO Dunwoody Business Excellence award and has also been the focus of television news segments dealing with provincial businesses. Ms. Johnston is a graduate of Ricks College in Rexburg, Idaho, and Brigham Young University in Provo, Utah. She holds both an Associate and a Bachelor's degree in Science, with an emphasis in marketing and merchandizing. She has been involved in customer sales and service for over 30 years.

Ms. Johnston is chairman of the board of the Community Futures Development Corporation of the Central Okanagan Board of Directors and also sits on its loan review committee. She has also been an active member in various feasibility studies in conjunction with the Science Council of BC. She was invited by the BC Minister of Agriculture to participate in a ground-breaking workshop with various agriculture sectors to make recommendations to the Ministry for policies and legislation that would permit continued growth and viability in the agriculture sector.

She currently resides with her family in Kelowna BC.

SAID - Ms. Johnston is owner and President of Nature's Formulae Health Products Ltd., a regulated industry stakeholder.

Dr. Katharina Kovacs Burn's academic (M.Sc., MHSA, Ph.D.), research and volunteer interests include public, patient and stakeholder engagement in health and social care decisions and policies which impact on patient safety, quality of life, effective evidence-based interventions and care practices, team-based health care access and equity.

As Associate Director, Health Sciences Council, University of Alberta, she coordinates inter-disciplinary and inter-professional health science research, education and practices, including with government, community and health partners. Her work and research link closely with volunteer community and committee work, including health charities and other organizations at the provincial (Creating Synergy Health Coalition), national (Patients for Patients Safety Canada, Best Medicines Coalition, Canadian Organization of Rare Disorders, National Neurological Initiative) and international levels (International Alliance of Patient Organizations, Institute of Health Economics); and Governments and institutions at provincial, national (Health Canada, Public Health Agency of Canada, National Standards for the Government of Canada, Canadian Patient Safety Institute, Canadian Health Institutes of Research), and international levels (South Africa Ministry of Social Development, World Health Organization).

She publishes, presents at special events, meetings and national and international conferences, as well as provides consultations on her research and volunteer initiatives.

Ms. Manon Lambert has been, since 2005, the Chief Executive Officer and Registrar of the Quebec Order of Pharmacists (QOP). Before joining the QOP, she was the Executive Director of the Association des Pharmaciens en Établissement de Santé, a professional union group representing Quebec pharmacists practicing in public healthcare establishments. In her 25 year career, Ms. Lambert has also held positions at the Réseau des Revues d'Utilisation des Médicaments, a provincial government-run common drug review, from 1991 to 1995. Prior to this she worked as a hospital pharmacist in three hospitals in Montreal from 1986 to 1991.

Ms. Lambert has been a member of several committees and other groups related to the pharmacy profession and the healthcare sector, namely the stakeholders meeting group of the Conseil du médicament, the faculty of pharmacy advisory board at the Université de Montréal, the Provincial Working Group on Pharmacy workforce planning and the Pharmacy Stakeholders Meeting Group.

Ms. Lambert's personal qualities, perfect knowledge of the pharmacy and pharmaceutical environment, leadership as well as professional commitment make her an important asset in QOP's main mission to protect the public, promote quality pharmaceutical care and appropriate use of medication in our society.

SAID - Ms. Lambert has professional affiliations with the Quebec Order of Pharmacists, a provincial professional regulatory body that may have an interest in the mandate and work of the NHP-PAC.

Mr. Gary Leong has over 15 years experience in the natural health products industry. He has managed the scientific and quality function for Boehringer Ingelheim, Natural Factors Nutritional Products Ltd. and Jamieson Laboratories Ltd. As Vice President of Scientific and Technical Affairs at Jamieson Laboratories, he is responsible for Quality Assurance, Quality Control, Regulatory and Consumer Affairs and Research and Development. Mr. Leong holds a B.Sc. in Chemistry and a M.B.A. in Quality Management.

SAID - Mr. Leong is a full-time employee of Jamieson Laboratories Ltd., a regulated industry stakeholder. As part of his function and expertise, Mr. Leong has participated as industry representative in meetings with Health Canada and has been volunteer speaker on regulatory Good Manufacturing Practice impact updates, including for the Canadian Health Food Association, the Council of Responsible Nutrition, the International Pharmaceutical Academy, Pharmaceutical Sciences Group, Hong Kong-Canada Business Association, the Canadian Functional Food and Nutriceuticals Mission (Taiwan) and the Toronto, Western Ontario, Guelph and McMaster Universities.

Ms. Shawn O'Reilly is the Executive Director and Director of Government Relations for the Canadian Association of Naturopathic Doctors (CAND). Ms. O'Reilly has been involved in the field of natural medicine for over 15 years holding senior positions with two of Canada's professional line nutraceutical companies and a holistic compounding pharmacy prior to joining the CAND in 2002. Previously, Ms. O'Reilly spent 17 years as a senior litigation law clerk and Law Clerk Manager for several top Canadian law firms.

SAID - Ms. O'Reilly is a full-time employee of the CAND, a national not-for-profit professional association that may have an interest in the mandate and work of the NHP-PAC . As part of her role and function with the CAND, Ms. O'Reilly may provide formal advice or opinion to the professional community on a matter of relevance to the NHP-PAC and may make public statements on issues of relevance to the NHP-PAC mandate, and she has participated in meetings with Health Canada.

Mr. Ron Rosenes (B.A.Hon, M.A.) has been an active member of the HIV/AIDS community in Toronto since 1991. Living with HIV since the early days of the epidemic and before the advent of therapies, he began to study complementary and alternative medicine (CAM) informally as a means to support his health. He is a former Russian and French professor who left the workforce in 1991 and began a volunteer life starting as a fundraiser with The AIDS Committee of Toronto (ACT), first as Chair of the AIDS Walk, then from 1995 to 1998 as Board Chair. He was appointed ACT's first Honorary Director in 1999. Mr. Rosenes is also a founding Board Member of the Sherbourne Health Centre, a new primary care clinic in downtown south-east Toronto that is home to a naturopathic and chiropractic clinic that offers free services to people with HIV. He is a long time member of AIDS ACTION NOW! Today, he devotes the bulk of his time to ensuring access to therapies for people with HIV including access to CAM as Vice Chair of the Canadian Treatment Action Council (CTAC), a non-government organization working in policy and advocacy at the national level. He sits on the Ontario Advisory Committee on HIV/AIDS, numerous scientific review committees and is delighted to be a member of the NHP-PAC.

Mr. Rosenes is a frequent contributor of articles on managing HIV disease using a holistic approach to such magazines as Living+ and The Positive Side.

SAID - Mr. Rosenes is a volunteer member of the CTAC, a national patient group that may have an interest in the mandate and work of the NHP-PAC. As part of his role and function with CTAC, Mr. Rosenes has participated in meetings with Health Canada including member of Health Canada advisory committees related to NHPs, and he has published an opinion piece on regulatory issues of relevance to NHPs.

Mr. David Skinner is a biochemist working in the health care field. After receiving a B.Sc. (Honours), he conducted laboratory research for the International Joint Commission, prior to an appointment to the National Research Council of Canada. He spent his early career conducting practical research.

In 1979, Mr. Skinner was invited to join Consumer Health Products Canada (formerly NDMAC) with Scientific and Regulatory Affairs responsibilities. Since 1983, he has held the position of President for this national trade organization. He has published research papers in a broad range of periodicals and has served on several advisory committees to governments, including federal committees to develop national health care policies. He has been involved in major health care reform initiatives such as the Provincial Health Commissions, Dr. Gagnon's review of Drug Regulatory Reform, Public service management audits and numerous Federal Advisory Committees on Natural Health Products.

Mr. Skinner's current appointments include board member for the World Self-Medication Industry, Co-chair of the Management Advisory Committee to the Assistant Deputy Minister of Health and member of the United States Pharmacopoeia.

Mr. Skinner has previously held appointments to the Ontario Provincial Pharmacy Advisory Board; the Advisory Committee to the Minister for International Trade; the Editorial Advisory Board, Canadian Pharmaceutical Association; the U.S. Centre for the Study of Aging; Technical Advisor to the Addiction Research Foundation; the Senior Management Review Committee, Health Canada; the Canadian Standards Association; Director of Pharmaceutical Advertising Advisory Board; a Founding Director of the Canadian Electronic Data Interchange; member of the Industry Liaison Committee for Natural Health Products; member of the Natural Health Products Directorate Management Advisory Committee; and, Director of the Canadian Foundation for Pharmacy.

Mr. Skinner's graduate studies in Science and Business were pursued in the U.S. and Canada.

SAID - Mr. Skinner is a full-time employee of Consumer Health Products Canada (CHPCanada), a national industry trade association that may have an interest in the mandate and work of the NHP-PAC. Mr. Skinner is a volunteer member of the Health Canada Advisory Committee on Management and may provide information as a witness to the Standing Committee on Health.

Mr. Ron Smith is the Vice President of Quality Systems for Factors Group of Companies. He completed undergraduate (B.Sc.) work in Chemistry and graduate (M.Sc.) work in the area of synthetic and analytical Carbohydrate Chemistry. He has spent the last twenty years in the pharmaceutical, nutritional supplement and cosmetic manufacturing industry in a series of progressive roles with responsibilities in the areas of Quality and Compliance, such as Quality Control, Quality Assurance, Regulatory Affairs and Validation, serving both domestic and international markets.

SAID - Mr. Smith is a full-time employee of the Factors Group of Nutritional Companies, a regulated industry stakeholder. As part of his role and function with Factors Group of Nutritional Companies, Mr. Smith is a volunteer participant on various Canadian Health Food Association, a national trade association that may have an interest in the mandate and work of the NHP-PAC, and industry round table groups, and may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC.

Ms. Barbara Wells established B.A. Wells Healthcare Consulting Inc in 2006. Prior to this, she was the founding Director of the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), one of three programs of the Canadian Agency for Drugs and Technologies in Health. Before joining COMPUS, she was founding Executive Director of the National Association of Pharmacy Regulatory Authorities (NAPRA), the national organization of Canada's provincial and territorial pharmacy licensing bodies.  During her time with NAPRA, she led a number of ground-breaking initiatives, such as the development of Canada's National Drug Scheduling System, Model Standards of Practice for Canadian Pharmacists, Professional Competencies for Canadian Pharmacists at Entry to Practice, and International Pharmaceutical Competencies.

Over her professional career, Ms. Wells has received national and international recognition for her work in public protection through professional regulation. Ms. Wells' career also includes corporate affairs and professional relations positions with a major multi-national pharmaceutical company, as well as pharmacy practice in both community and hospital settings.

A graduate of the University of Toronto's Faculty of Pharmacy, Ms. Wells is a licensed pharmacist in Ontario.

Working Group #1 - Standards of Evidence for Non-Traditional Natural Health Products

See section Committee for biographies and summaries of affiliations and interests declarations of Active Committee Members who sat as members of Working Group #1.

• Ms. Shawn O'Reilly (Co-chair)
• Mr. Ron Rosenes (Co-chair)
• Mr. Carl Carter
• Ms. Barbra J Johnston
• Ms. Leah Stephenson (Alternate Member) is Executive Advisor at the Canadian Treatment Action Council and was Coordinator of Best Medicines Coalition, both national patient/consumer networks. She is a consumer of natural health products and used them extensively as complementary therapies to support her mother in her battle with cancer.
• Mr. David Skinner
• Ms. Barbara Wells

Non-Committee Members

Ms. Serenity Aberdour (N.D.) graduated as a Naturopathic Physician from the Canadian College of Naturopathic Medicine (CCNM) in 2002. She was part time faculty member at CCNM (2003/4) and has been in private practice since 2002. She is currently practicing in Vancouver, British Columbia. Ms. Aberdour has been Manager of Science and Education, SISU Inc., since 2004, where her duties include product research and development and preparation of safety and efficacy summaries for submission of natural health product licence applications to Health Canada. She was Trial Clinician for a CCNM Cardio Pilot Study (Vancouver site), a project funded by Canada Post and completed in 2009.

Ms. Roxy Campbell holds a B.Sc. in Food Science from the University of Alberta. She has over 25 years of industry work experience in the food and natural health products industry with the focus on quality control, quality assurance, research and development, and regulatory affairs.

SAID - Ms. Campbell is an employee of Natural Factors Nutritional Products, Inc., a regulated industry stakeholder, where as part of her role and function, she may participate in advisory groups and meetings with Health. Ms. Campbell is also a member of the Canadian Health Food Association (CHFA), a national industry trade association which may have an interest in the mandate and work of the NHP-PAC. As part of her role and function with the CHFA, she may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC.

Dr. Peter Jones (Ph.D.) holds a B.Sc. (1978), M.Sc. (1981) and Ph.D. (1984) from the University of British Columbia . He is Canada Research Chair in Nutrition and Functional Food and Professor and Director of the Richardson Centre for Functional Food and Nutraceuticals at the University of Manitoba, since 2005. He was also research Associate at the University of Chicago (1984-86) and Professor at the University of British Columbia (1986-1994), Professor and Chairman at McGill University (1994-2005) and has been President of Nutritional Fundamentals for Health since 2004. Mr. Jones was a recipient of the Canadian Society for Nutritional Science, Young Investigator Award, in 1997.

Dr. Jones is Vice-President, Danone Institutes International and President, Danone Institutes of Canada. He has authored/co-authored over 250 peer-reviewed journal articles and 25 book chapters.

Ms. Marie Jutras graduated as a naturopath from the Institut International de Recherches en Homéopathie et Biothérapies (IIRHB) in Montreal in 1993. She also graduated in ecological horticulture from the Centre de formation agricole de Mirabel in 1999. Ms. Jutras is an herbalist who has been in the employ of Clef des Champs since 1999, where she prepares the compendium of Clef des Champs products, gives lectures, is responsible for the harvesting and processing of medicinal plants, and is the regulatory affairs officer. She has been a phytotherapy instructor at IIRHB, and was responsible for the harvesting and processing of medicinal plants at the University of Guelph's Alfred College (2001-2006). Ms. Jutras is a member of the Guilde des herboristes and editor-in-chief of the guild's journal, and is the guild's representative on the Canadian Council of Herbalist Associations.

SAID - Ms. Jutras is an employee of Clef des Champs Inc., a regulated industry stakeholder. She is also volunteer member of La Guilde des herboristes, a provincial professional and industry trade association, and the Canadian Council of Herbalists Associations, a national professional society that may have an interest in the mandate and work of the NHP-PAC.

Dr. Paul Saunders (Ph.D., N.D., D.H.A.N.P., C.C.H.) is Professor of Materia Medica and has a private practice in Dundas, Ontario. He has a Ph.D. in plant ecology from Duke University and was on the faculty at Clemson and Washington State Universities, earning tenure at WSU. He earned his Naturopathic Doctor (N.D.) degree from the Ontario (now Canadian) College of Naturopathic Medicine and did additional training and residency at the National College of Naturopathic Medicine in Portland, Oregon, earning a second N.D., and served as their interim Research Director. Dr. Saunders earned a Diploma from the Homeopathic Academy of Naturopathic Physicians and a Certified Classical Homeopath from the American Council on Homeopathic Certification in 1993. He completed chelation board examinations from the International College of Integrated Medicine in 1998. As editor of the Canadian Journal of Herbalism, 2000-2002, he instituted peer-review. He has been doing grant reviews for the National Institutes of Health (NIH) and National Center for Complementary and Alternative Medicine of the NIH since 2000. He was honoured as Ontario Naturopathic Doctor of the Year, in 1994 and 2002. In 1999, he was a member of the Transition Team that created Health Canada's Office of Natural Health Products (now the Natural Health Products Directorate) and served on its Expert Advisory Committee, 2000-2006. He has co-authored two books, conducted research, published numerous papers and lectured frequently on naturopathic medicine.

Mr. Brian Wagner is a member of the Canadian Health Food Association (CHFA) Regulatory Affairs Advisory Council and played a leading role in the development of the CHFA's standards of evidence proposal, which served as a seed document for Working Group #1 of the NHP-PAC. Mr. Wagner's natural health product consulting practice is located in Victoria, British Columbia.

SAID - Mr. Wagner is owner and President of NHP Consulting Inc., a regulatory consulting firm with the regulated industry of relevance to the NHP-PAC.

Working Group #2 - Product Testing Requirements Connected to Good Manufacturing Practice Requirements for Natural Health Products

See section Committee for biographies and summaries of affiliations and interests declarations of Active Committee Members who sat as members of Working Group #2.

• Ms. Paula Brown (Chair)
• Mr. Carl Carter
• Mr. Joseph Chan
• Mr. Lawrence Cheng
• Ms. Suzanne Gaudette
• Mr. Gary Leong

Non-Committee Members

Dr. Steven Dentali (Ph.D.) is Chief Science Officer at the American Herbal Products Association (AHPA) where his duties include helping to set quality standards for the botanical products industry and providing guidance and advice to AHPA member companies, related organizations, government agencies, scientific publishers and the popular press. He is a United States Pharmacopoeia (USP) Convention Delegate and a member of the USP Committee of Experts, Dietary Supplements - General Chapters. He is also Editorial Board Chair of AOAC INTERNATIONAL and Secretary of their Presidential Task Force on Dietary Supplements. An advisory board member of the American Botanical Council and the American Herbal Pharmacopoeia, he also chaired the Product Quality Working Group of the National Advisory Council for the US Center for Complementary and Alternative Medicine at the National Institutes of Health from 2005 to 2007.

Dr. Dentali has nineteen post graduate years experience in the US herbal and dietary supplement industry having worked with small craftsmanship botanical houses, large and small agricultural efforts, and as Senior Director of Botanical Sciences for a large corporate supplement company. He was trained as an herbalist prior to earning his doctorate in Pharmaceutical Sciences with a specialization in Natural Products Chemistry from the University of Arizona, Tucson. An American Foundation for Pharmaceutical Education Fellow, Dr. Dentali's understanding of traditional uses of therapeutic herbs gives him a unique perspective on the emerging scientific data on medicinal botanicals. Recognized as a foremost expert in the natural products industry and a frequent lecturer, he is considered an authority on botanical product quality issues and is known to be an active participant in discussions with organizations and institutions that have an interest in herbal and other natural health products.

SAID - Dr. Dentali is a full-time employee of the American Herbal Products Association (AHPA), an industry trade association that may have an interest in the mandate and work of the NHP-PAC. As part of his role and function with the AHPA, Dr. Dentali advises the International Aloe Science Council, another trade group. As part of his volunteer role as member of the US Pharmacopeia and Editorial Board Chair of AOAC International, he may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC.

Mr. Richard Lenz holds a B.Sc. with a combined double major in chemistry and biochemistry. He has over 16 years of Canadian natural health product solid dosage Good Manufacturing Practices industry work experience, primarily in the areas of analytical chemistry, quality control, quality assurance, formulation and validation. He has worked in positions ranging from scientist to senior manager.

SAID - Mr. Lenz is an employee of Factors Group of Nutritional Companies, a regulated industry stakeholder. He is also a volunteer member of Canadian Health Food Association, a national industry trade association that may have an interest in the mandate and work of the NHP-PAC.

Mr. Bernd Licht has been managing Quality Assurance and Regulatory Affairs for 13 years and is currently employed by Puresource Inc., a national manufacturer, importer and distributor of natural health products, food, cosmetics, consumer products and medical devices that sell into independent health food, grocery and pharmacy stores. Mr. Licht has been actively involved with Canadian Health Food Association regulatory advisory groups for approximately 10 years and was a member of the Natural Health Products Good Manufacturing Practice (NHP GMP) workgroup that provided background documents for current NHP GMPs. Puresource Inc. has a dedicated product licensing group and has submitted approximately 855 NHP product licence applications since January 2004.

SAID - Mr. Licht is a full-time employee of Puresource Inc., a regulatory industry stakeholder, which has membership with the Canadian Health Food Association (CHFA), a national industry trade association that may have interest in the work and mandate of the NHP-PAC. As part of his role and function as Puresource Inc. Quality Assurance and Regulatory Affairs Manager, Mr. Licht participates in CHFA regulatory/technical advisory groups and in bilateral meetings with Health Canada's Natural Health Products Directorate, and may provide formal advice or opinion to the regulated industry on a matter of relevance to the NHP-PAC.

Mr. William Morkel holds an Honours Bachelor of Science in Biology and Physics from the University of Toronto with minors in Human Physiology and History. He completed a one year Pharmaceutical Regulatory Affairs and Quality Assurance Certificate Program at Seneca College and has over ten years of experience working in the field of pharmaceutical and natural health products quality assurance. His background includes professional teaching, training and auditing to both Good Manufacturing Practice (GMP) and ISO standards. Mr. Morkel regularly attends professional development courses and workshops and often delivers lectures on GMP issues. He currently holds the position of Senior Regulatory and Quality Assurance Specialist at Dicentra Inc.

Dr. Jon-Paul Powers (Ph.D.) holds a Ph.D. in Microbiology and Immunology from the University of British Columbia and a B.Sc. in Biochemistry from Carleton University. Dr. Powers is a former assessment officer and acting unit head at Health Canada 's Natural Health Products Directorate and is currently the Director of Scientific Affairs at Body Plus Nutritional Products Inc. where he oversees all aspects of regulatory affairs, quality assurance and quality control.

SAID - Dr. Powers is a Director and employee of Body Plus Nutritional Products Inc., a regulated industry stakeholder and he was employed, 2008-2009, as a regulatory consultant by Dicentra Inc., also a regulated industry stakeholder.

Mr. Colin Watson holds a Bachelor of Science degree from the University of Waterloo with a major in Organic Chemistry. He also completed a Biochemical Technology Diploma (Honors) at Seneca College. Mr. Watson has over 20 years of experience in the ethical, generic, over the counter pharmaceutical and natural health products industry. He is also an active member of the Canadian Health Food Association expert regulatory group responsible for developing standards of evidence and minimum testing requirement proposals for review by Health Canada's Natural Health Products Directorate.

SAID - Mr. Watson is a full-time employee of Swiss Herbal Remedies, a regulated industry stakeholder and member of the Canadian Health Food Association, a national industry trade association which may have an interest in the mandate and work of the NHP-PAC.

Working Group #3 - Compliance and Enforcement for Non-traditional Natural Health Products

See section Committee for biographies and summaries of affiliations and interests declarations of Active Committee Members who sat as members of Working Group #3.

• Ms. Suzanne Gaudette (Chair)
• Ms. Paula Brown
• Mr. Carl Carter
• Mr. Joseph Chan
• Mr. Lawrence Cheng
• Ms. Barbra J Johnston
• Ms. Manon Lambert
• Mr. Gary Leong
• Ms. Shawn O'Reilly
• Mr. Ron Rosenes
• Mr. David Skinner
• Mr. Ron Smith
• Ms. Leah Stephenson
• Ms. Barbara Wells

Health Products and Food Branch (HPFB) Advisory Body Member Affiliations and Interests Declaration

Each HPFB advisory body member is responsible for the declaration of his or her interests, and the interests of their spouse/partner and/or dependent child. The Affiliations and Interest Declaration forms are updated annually or when there is a change in a member's status. The summary of declaration is made available on the Health Canada website in accordance with the HPFB commitment to be transparent about the membership of its advisory bodies.

Prior to every meeting, the chair will review members' declarations in light of the various items on the agenda. Based on this review, a decision is taken, if necessary, to reduce or refuse a member's participation for all or parts of the meeting agenda, and communicated to the member. Upon receipt of the meeting agenda, members are also expected to review their own affiliations and interests against agenda items and advise the chair and secretariat if they see a potential cause for concern regarding the integrity and objectivity of their participation.

In accordance with the HFPB Review of Regulated Products: Policy on Public Input and Guidance on Advisory Bodies, a person with a direct financial interest in the outcome of a review of a regulated product, or class of products, may be a member of an advisory body whose mandate encompasses matters of policy, management, or program development. However, such a member may not participate in any discussion, formulation of advice, or recommendations by the advisory body to the Branch relating to that review.

HPFB advisory body members provide information on the following affiliations and interests areas:

Direct financial interests

• 1. With the regulated industry of relevance to the NHP-PAC mandate, including current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares, or bonds, with the regulated industry.

Indirect financial interests

• 2. Within the last five years, received from the regulated industry payment for work done or being done, or financial support, of relevance to the NHP-PAC mandate including past employment, contracts, consulting, research support, personal education grants, contributions, fellowships, sponsorships, teaching honoraria, other than present employer.
• 3. Within the last five years, materials, discounted products, gifts or other benefits, or attendance at meetings where all or part of the travel and accommodation costs provided by the regulated industry, other than from present employer, over $1,000.
• 4. Within the last three years, received grants or other funding from the regulated industry to any of the organizations where you are currently employed or participate in internal decision-making, for example as board member, or executive or non-executive director.

Intellectual interests

• 5. Within the last five years, provided any formal advice or opinion to the regulated industry, a government or non-government organization on a matter of relevance to the NHP-PAC mandate, including expert testimony or acting as witness (full or part time), participation on an advisory body, etc.
• 6. Within the last five years, made a public statement, including speeches, lobbying, etc., or publicly stated a point, of view, including scientific papers, articles, journals, or other publications or on Web sites, on issues of relevance to the NHP-PAC mandate.
• 7. Currently have any professional or volunteer affiliations such as membership of professional/scientific societies, trade associations, lobbying, public interest or advocacy group, etc., who may have an interest in the mandate and work of the NHP-PAC.

Other

• 8. Any other affiliations and interests or potential circumstances that might give a well informed member of the public reasonable grounds for concern regarding the integrity and objectivity of your participation in the NHP-PAC.