GMP UPDATE 2008

Dr. Dandiker completed his Masters and Doctorate in Biochemistry from the University of Salford in the U.K., after which he joined Upjohn (now Pfizer). In 1987, Dr. Dandiker moved to Glaxo Smith Kline where he spent ten years in various roles in New Product Development. During this period, Dr. Dandiker completed an MBA Program from the Open Business School in the U.K. He then joined Roche in 1997 where he headed up Pharmaceutical Development in the U.K. In 2001, Dr. Dandiker joined IVAX Pharmaceuticals (now TEVA). In March 2004, Dr. Dandiker moved to Toronto to take up the position of Vice President, Product Development (Solids) at Apotex Inc.

John Groskoph has more than 17 years of pharmaceutical industry experience with a particular focus on CMC regulatory compliance. During his career at Pfizer, John has worked in a variety of quality operations and production assignments and brings experience in Quality & Compliance Systems, post-approval change management and regulatory strategy. He joined the Manufacturing Control department in 1998 as Manager, Manufacturing Control. He was appointed Director, Global Manufacturing Compliance in 2001. In 2002, he took a one-year assignment in the Arnprior, Canada plant where he held various responsibilities in both the Quality and Manufacturing Teams. Prior to his current position, John held the position of Team Leader, Quality Compliance Programs at the Parsippany, NJ manufacturing site. John holds a B.S. in Electrical Engineering from Lafayette College, Pennsylvania and an M.B.A. from Columbia University, New York.

Mr. Hulihan is Corporate Compliance Officer and Vice President of Global Regulatory Affairs and Quality Assurance at Medidata Solutions Worldwide. Prior to joining Medidata, Mr. Hulihan was Senior Vice President, Regulatory Consulting Services at META Solutions and Vice President, Quality Systems at EduQuest – both internationally recognized GXP Consulting firms. During his tenure at these firms, Mr. Hulihan provided regulatory consulting, auditing, and training services to the global pharmaceutical, biologics, and medical device industries. Mr. Hulihan has also provided advice and training to regulatory agency personnel within the U.S. Food and Drug Administration [FDA], European and Asian communities. Over the past few years, Mr. Hulihan’s extensive involvement with the Chinese SFDA has included establishing and directing SFDA training programs for their industry throughout China.

Mr. Hulihan has functioned in the Global GXP Regulatory Environment for over 30 years, primarily in the areas of Quality Assurance, Regulatory Affairs, Clinical Research, Drug Development, Drug Safety and Quality Systems. This includes Senior Quality Assurance positions in the Global Pharmaceutical Environment [Pharma and CRO] as well as over 12 years in Clinical Medicine and Clinical Research at The University of Medicine and Dentistry of New Jersey. Clinical areas of involvement included the Cardiovascular, Pulmonary, and Endocrine areas of Medicine as well as Psychiatry.

Mr. Hulihan has extensive international experience in Quality Assurance, Regulatory Compliance, the GXP Environment, Devices, Drug Safety and Computer Validation. Mr. Hulihan has been active in the industry since the mid 1970’s and is often called upon to speak and serve as chair in many industry International conferences. He currently serves as co-chair of several DIA International programs and Workshops. Mr. Hulihan directs or is a faculty member of several International technical courses as well. Mr. Hulihan is a featured speaker at conferences around the world on Data Quality and Integrity, Quality Assurance, Regulatory, Drug Safety/Pharmacovigilance and Outsourcing.

He is the former Chair and continues to be active with the DIA’s Validation SIAC and Good Clinical Practices and Quality Assurance SIAC, co-chair of the DIA Advisory Council for North America, on the Editorial Boards of the Guide to Good Clinical Practice, Guide to Pharmacovigilence and Safety, Pharma IT and BioIT Journals. Mr. Hulihan is also a Contributing Author to the textbooks, New Drug Approval Process with sections on Quality Assurance, China and HIPAA and ‘Computerized Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance (AKA - Red Apple II)’. He is chair of the Global Clinical textbook effort, ‘Computerized Systems in Clinical Research: Current Quality and Data Integrity Concepts’.

Mr. Hulihan has received awards from various International organizations including the American Heart Association’s “Distinguished Honors Award” and the Drug Information Association’s highest honor – the prestigious “Founders Service Award”. Mr. Hulihan has also been found listed in ‘Who’s Who in the Computer Industry’. In January 2008, he was appointed “Visiting Professor” at the prestigious Shanghai University of Traditional Chinese Medicine. During the next two years, he will be focused in assisting the University as it expands its Traditional Chinese Medicine Clinical Program. He is the first Westerner to be so appointed.

Eileen McMahon is the co-chair of Torys' Intellectual Property Practice. She practises exclusively in the areas of intellectual property and food and drug regulatory law. She is one of a handful of Canadian lawyers who advise on regulatory clearance and intellectual property protection of products. Eileen is a registered patent and trademark agent in the United States and Canada.

Eileen’s experience includes strategic advice on identifying intellectual property and regulatory assets; obtaining and maintaining market exclusivity using intellectual property and regulatory laws; exploiting intellectual property assets; and enforcing intellectual property rights.

Robert Noack is a 1991 graduate of the University of Michigan with a B.S. in Chemical Engineering. After graduation, Robert joined Perrigo Company in Allegan MI. During his time with Perrigo, Robert worked in a variety of positions ranging from Quality Control to Technical Support and Development. In these roles he focused on the scale up and validation of solid dose processes.

In 1999, Robert joined Pfizer (Pharmacia), Global Research & Development Pharmaceutical Sciences Formulations group, where he worked as the Principal Investigator on multiple project teams and multiple drug delivery platforms. In 2003, Robert joined the Clinical Supply organization and has played many roles – group leader manufacturing technology support, manager of operations and most recently head of manufacturing coordination and operations support.

While working in these roles, Robert has helped introduce new technologies and new work processes into a GMP environment. Robert also published several peer-reviewed technical articles and presented in pharmaceutical conferences in the topics of roller compaction, powder in capsule technology, continuous coating, six-sigma, and lean manufacturing.

Shigeru F. Hayashi jointed Pfizer in 1990 as a research scientist (microbiologist) in Veterinary Medicine Discovery, Pfizer Animal Health, Pfizer Inc. He worked on the veterinary specific medicines, particularly long acting antibiotics for livestock and companion animals.

In 2002, Shigeru joined New Product CMC, Global Chemistry Manufacturing & Control as a US-based Japan Project Coordinator. Since then, he has been working on many Japanese filings.

Last year, Shigeru served as an organizer for the following two Japan CMC workshops in the US; PDA Annual Meeting, March, Las Vegas, and PDA/FDA Joint Regulatory Conference, September, Washington DC.

Shigeru is native born Japanese and has been living in US since 1979. He has BS in Agricultural Chemistry from Iwate University, Morioka, Japan, and MS and PhD in Agricultural Chemistry/Soil Microbiology from Tohoku University, Sendai, Japan.

Gary has over ten (10) years experience in the Natural Health Products industry. He has managed the scientific and quality function within Boehringer Ingelheim, Natural Factors Nutritional Products Lt. and Jamieson Laboratories Limited. As Vice President of Scientific and Technical Affairs, at Jamieson Laboratories, Gary is responsible for Quality Assurance, Quality Control, Regulatory and Consumer Affairs and Research and Development. Prior to coming to the Natural Products industry, Gary held various research and management positions at the radiopharmaceutical division of Atomic Energy of Canada Limited (AECL) for nine (9) years. Gary holds a B.Sc. in Chemistry and a M.B.A. in Quality Management.

Kwasi A. Nyarko is currently Manager of Special Projects Unit, Policy and Promotion Division, Centre for Policy and Regulatory Affairs, Biologics and Genetic Therapies Directorate, Health Canada. Kwasi has been involved in the development of a number of science-based policies, guidance documents for industry, as well as development of national standards and regulations related to biologic and genetic therapies for human use. At Health Canada, Dr. Nyarko has also worked with post market surveillance of marketed biologic and biotechnology products. The focus of the Special Projects Unit is to enhance the efficiency of the regulatory process for biologics and genetic therapies.

Ms Sara O'Connor is currently acting as Manager of the Sumbission Management Division within the Bureau of Product Review and Assessment at the Natural Health Products Directorate in Ottawa, ON. Ms. O'Connor joined NHPD in 2004, shortly after the Natural Health Product Regulations came into force and has since been involved in developing and implementing process improvements and backlog elimination strategies.

Dr. Saffari is a Quality Assurance specialist with more than 17 years of direct working experience in implementation of GMP regulations, inspection, quality control, manufacturing, analytical method development including method validation and process validation of pharmaceutical products. He has In-depth working knowledge of cGMP and thorough understanding of international regulatory agencies (FDA, WHO, ICH and EMEA) requirements.

Dr. Saffari has successfully launched two products manufactured by Biogen in the US market with an FDA approval, "Avonex" ß-interferon injection for the treatment of Multiple Sclerosis received FDA approval in 1997 and"Ameviv" for the treatment of chronic plaque Psoriasis (skin disorder) received FDA approval in 2001

Prior to joining WHO, Dr. Saffari was the Director of Quality Assurance at Pacific Pharmaceutical in Pakistan, where he directed and led Pacific Pharmaceutical to the state of GMP compliance for filling with European Health Ministry and subsequently received the certificate of "GMP compliance of manufacturer" from European Union in 2007.

Dr. Saffari obtained his undergraduate degree from University of Illinois at Urbana and his Doctorate from University of Nebraska in the field of chemistry.

Chad Sheehy is the Manager of the Drug GMP Inspection Unit in the Compliance and Enforcement Coordination Division of the Health Products and Food Branch Inspectorate of Health Canada. Mr Sheehy started in Health Canada as a post market evaluator of natural health products before moving to drug compliance verification and investigations and then drug GMP inspection.

Mr Sheehy chairs Health Canada’s Drug GMP Committee (a technical advisory committee) and represents Canada at the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

He is a graduate of Dalhousie University and the Canadian College of Naturopathic Medicine.

The HPFB Inspectorate’s GMP Inspection Policy and Conditions for Acceptance of Foreign Inspection Reports

Irwin Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients.

He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked for over 17 years with the International Pharmaceutical Excipients Council (IPEC) developing guidance documents for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration to educate the agency and public on these documents. He has been consulting to both the pharmaceutical and excipient ingredient industries since 2000.

Christopher Smith is responsible for the management and leadership of AAIPharma’s Regulatory Affairs and Quality departments. AAIPharma Inc. is a provider of contract materials manufacturing; analytical, microbiological and bioanalytical methods development, validation and testing; stability storage and testing; pharmacokinetic and Phase I through IV clinical trials; pharmacovigilance; and regulatory and quality assurance consulting.

Mr. Smith has 30 years of experience in the pharmaceutical industry having held positions at the FDA, large and small pharmaceutical companies, and at a contract research organization. Prior to his current position, Mr. Smith was Vice President, Regulatory Affairs and Quality Assurance at Endeavor Pharmaceuticals, a start-up company focused on the development of therapies in the women’s health field. Mr. Smith joined Endeavor after nine years at AAI where he served on the Executive Committee and held the position of Vice President, Regulatory Affairs and Quality Assurance Worldwide. He joined AAI in 1992 following five years as Associate Director of Regulatory Affairs at Abbott Laboratories. Mr. Smith began his regulatory career as an Investigator in the Detroit District of the U.S. Food and Drug Administration and spent 12 years with FDA in positions of increasing responsibility including Assistant Director of Congressional Operations, Associate Director of Program Management and Deputy Associate Commissioner for Public Affairs in Rockville, MD.

Mr. Smith has a Bachelor's degree from Michigan State/Oakland University, Rochester, MI, and a Master's degree in Microbiology from Wayne State University, Detroit, MI. He is a member of the Drug Information Association, the Regulatory Affairs Professional Society (certified RAC), the Parenteral Drug Association, and the American Society for Quality (certified CQE). He has several publications including "Laboratory Operations: A Vital Link," GMP Compliance, Productivity, and Quality (Interpharm Press, 1998) and “A Fish Story: The One That Got Bigger,” When Lightning Strikes (WBBI 1994) and Communicating in a Healthcare Crisis (FDA News “Speed Dating: the Rapid Way to Phase I Clinical Studies,” PMPS Journal (Winter 2007). He is a sought-after speaker and panel participant on regulatory and quality issues affecting the pharmaceutical industry and has presented on topics including drug development, GMPs, laboratory compliance, outsourcing, stability, cleaning validation, PAIs, FDA interactions, and controlled substances.

John Taylor is the Quality and Standards Manager for the UK medicines and medical devices regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

John joined the Agency in 1991 after working in the pharmaceutical industry for 24 years in quality control, quality assurance, research and development and regulatory affairs. He joined the regulator as a medicines inspector and then moved onwards and upwards to develop and implement the Agency’s quality management system. In addition to specialising in quality management, John is a recognised authority on good distribution practice of medicinal products. He is a member of the European Compliance Academy Advisory Board and Qualified Person Association.

John is a Chartered Chemist and a Fellow of the Royal Society of Chemistry.

Since founding the company in 1996, Anne has grown canreg to include more than 100 in-house consultants and staff. Prior to starting canreg, Anne worked for 20 years at Searle Canada. Her last role at Searle was as a Business Unit Director and included responsibility for regulatory affairs, provincial and private payer reimbursement, customer interface, legal and information services. Before joining Searle, Anne also spent time at Hoffman La-Roche and Wyeth. She has written and lectured extensively on regulatory affairs. In addition to training courses, Anne is also an instructor for the Post-Graduate Regulatory Affairs Program at Humber College in Toronto.

Marion has over 32 years of quality systems experience working in both the medical device and pharmaceutical industries. She has held leadership positions in Quality Assurance at Johnson and Johnson, Syntex Pharmaceuticals and Roche. She is the President of Marion Weinreb & Associates, Inc., (MWA), a full service international consulting company with over 160 associates located in the US, EU, Canada, and India, specializing in GCP, GLP, and GMP quality systems and regulatory compliance. MWA provides consulting expertise from development through commercialization for the pharmaceutical, biotechnology, and medical device industries. Marion and MWA associates have performed over 500 audits at clinical, GLP and GMP service providers, and have assisted with over 50 Pre-Approval Inspections. Marion and MWA provide standardized and customized training in GMP, GLP and GCP. MWA is a WBENC certified business.