Advisory Board. Advisory Board. Advisory Board (1) GMP Manual (Up05) Maas & Peither AG GMP Publishing

Size: px

Start display at page:

Download "Advisory Board. Advisory Board. Advisory Board (1) GMP Manual (Up05) Maas & Peither AG GMP Publishing"

Sibyl Mary Freeman
6 years ago
Views:

1 (1)

Virginia G. Beakes-Read Genentech, USA Ginny works for Genentech, Inc., as the Director, Regulatory Policy Liaison, for the Strategic Operations Office in Washington, D.C.

She recently left the FDA where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy in CDER for almost 8 years.

2 Virginia G. Beakes-Read Genentech, USA Ginny works for Genentech, Inc., as the Director, Regulatory Policy Liaison, for the Strategic Operations Office in Washington, D.C. She works on a variety of policy and regulatory issues affecting Genentech. She recently left the FDA where she was the Director, Division of Regulatory Policy II, Office of Regulatory Policy in CDER for almost 8 years. Prior to her tenure at FDA, Ginny was a US Army JAG for 6 years, focusing primarily on criminal law matters. She is also an RN and started her career as a US Air Force Nurse, working in intensive care units for 6 years. Rafael Beaus Codes B&B Asesores, Spain Rafael is pharmacist (University of Barcelona) and Master in Production Management ( Escuela de Administración de Empresas, Business Administration School of Barcelona). (2) Rafael currently is General Manager of AFAQUIM (Bulk Pharmaceutical and Fine Chemicals Producers Association) and General Manager of AUDIT GMP. Pharmaceutical Industry 3 rd Party Auditors as well as Board Member of the REAL FARMACO- PEA ESPAÑOLA and Professor in the Barcelona University, Pharmacy Department. Before he hold leading positions in numerous companies such as Technical Director and Executive Vice-president of GEMA-BIOCHEMIE. (Sandoz), General Manager and Technical Director of L.I.E.S.S.A. (DSM), Technical Director of Laboratorios Alcon-Cusí, S.A., Technical Director in Laboratorios Hosbon S.A. (Aventis) and Technical Director of Laboratorios Hosbon-Brazil. He was and is engaged in numerous associations as Board Member (GEMA- BIOCHEMIE, ITESBA S.A., LIESSA, DERIVADOS DEL ETILO S.A, LABORATORIOS HOS- BON DO BRASIL, FEIQUE), president (AFAQUIM, AEFI) or official delegate (REAL FARMACOPEA ESPAÑOLA, APIC, UNIDO, EUROPEAN PHARMACIST GROUP)

Daniel Harpaz, MSChE, MBA, PhD has over 35 years experience in the pharmaceutical industry, where he held diversified positions in research and development, quality control and engineering, at Merck,

3 Daniel Harpaz, Ph.D. Dr. Harpaz holds a B.S. and M.S. in Chemical Engineering, MBA in Systems Management and a Ph.D. in Industrial Pharmacy. He publishes and lectures on GMP and Validation issues for APIs, and for Dosage Forms. Daniel Harpaz, MSChE, MBA, PhD has over 35 years experience in the pharmaceutical industry, where he held diversified positions in research and development, quality control and engineering, at Merck, Sharp and Dohme; Revlon Health Care; Mennen, and Dell Laboratories. In 1993 he established Harpaz Consulting Services which provides technical and regulatory support to API and dosage form manufacturers worldwide. He is the co-editor of the book Validation of Active Pharmaceutical Ingredients 2nd edition, Distributed by Taylor and Francis Publishing. Lothar Hartmann, Ph.D. F. Hoffmann-La Roche, Switzerland Chair Lothar attended the Technical University of Berlin to study chemistry where he achieved his Diploma and Ph.D. Lothar Hartmann wrote the following chapter for the GMP Manual: chapter 21 GMPs for APIs Since the beginning of the new millennium he is Head of External Relations of Roche s Global Quality department, interacting with regulatory health authorities and associations. Lothar served for approximately 10 years on the board of APIC/CEFIC as Vice- Chairman. He was member of the ICH Expert Working Group ICH Q7a. Currently he takes various functions in EBE (European Biopharmaceutical Enterprises) and PDA (Parenteral Drug Association). (3)

Before he was a Senior GMP-Inspector at the State Agency for Health and Occupational Safety of Land Schleswig-Holstein (1994 to 2005) and headed an Official Medical Control Laboratory (1991 to 1994).

4 Michael Hiob, Ph.D. Ministry for Health of Land Schleswig-Holstein, Germany Michael studied Pharmacy at the University of Kiel. Since 2005 he is head of the medicinal products, pharmacies and narcotics section and in charge of the supervision of the GMP-inspection services at the Ministry for Health of Land Schleswig-Holstein. Before he was a Senior GMP-Inspector at the State Agency for Health and Occupational Safety of Land Schleswig-Holstein (1994 to 2005) and headed an Official Medical Control Laboratory (1991 to 1994). Michael is working as an expert in numerous committees, e.g. of EMEA and ICH. He is a founding member and chairman of the German expert working group Qualification/Validation and associate lecturer at the University of Kiel. Yukio Hiyama National Institute of Health Sciences, Japan National Institute of Health Sciences, the Ministry of Health, Labour and Welfare, Japan. Yukio Hiyama received Ph.D. degree in 1979 in Chemistry from University of Tokyo. His current position is Chief, Third Section, Division of Drugs, NIHS, MHLW. Responsibilities include research on pharmaceutical quality control and training of GMP inspectors. He leads an industry-government Human Science project on analytical method development for pharmaceutical development. He also leads MHLW's study groups to draft GMP related guidances and to propose the regulatory framework under the revised Pharmaceutical Affairs Law. He is an adviser to New Drug Application assessment and a member of JP Chemical Monograph Committee. He has been involved in the ICH for Q8 and Q9. He is currently Q10 topic leader for MHLW. His previous work experiences include scientist and director positions in Pharmaceutical Development in Upjohn Co. in US and in Japan, Visiting Associate: National Institutes of Health, Bethesda MD USA and Post-doctoral research associate: Department of Chemistry, University Illinois, Urbana IL USA. (4)

Before Harri was Head of Department Enforcement and GMP Inspections, National Agency for Medicines (1993 1999), GMP-inspector, National Board of Medicines (1984 1992) and Production Pharmacist,

5 Harri Juhani Ikäläinen Orion Corp., Finland Harri holds a B.Sc. and M.Sc in Pharmaceutical Sciences of the University of Helsinki. Since 2000 he is Vice President, Quality Management at Orion Corporation. Before Harri was Head of Department Enforcement and GMP Inspections, National Agency for Medicines ( ), GMP-inspector, National Board of Medicines ( ) and Production Pharmacist, Finnish Defense Forces ( ). Harri occupied numerous positions such as Chairman of PIC PIC/S, EFTA observer at EC Commission Working Party of Inspections, Finnish Delegate of EMEA ad hoc Working Group of GMP Inspections, Substitute Member of Management Board of EMEA, Member of Supervisory Committee, National Agency for Medicines Finland, Chairman of Pharmaceutical and Technical Working Group of the Finnish Pharmaceutical Industry and Member of EFPIA Working Group on Manufacturing and GMP. Michel Keller Swissmedic, Switzerland Michel is a graduate biologist from the University of Fribourg, Switzerland. Since 1997 he is inspector of manufacturers of dosage forms including distributors and APIs with Swissmedic, the Swiss agency for therapeutic products. Before Michel was QA manager in a Swiss medium size pharmaceutical company, specialised in the development of galenical formulations. Michel has worked in ICH (Q7a, GMPs for APIs), is participant to the EDQM (European Department for the Quality of Medicines) inspection programme for CEP (Certification of Suitability of the European Pharmacopoeia), member of the PIC/S Executive Committee and MRA officer for the MRA between Canada and Switzerland. (5)

Josef worked in various groups of APIC/CEFIC and is specialized in Quality Management Systems.

6 Josef Kuenzle, Ph.D. Permamed Switzerland Josef holds a Ph.D. in chemistry of the University of Zurich and a Post-Doc of Stanford University. Since 2003 Josef is Head of Quality Management of Permamed AG, Switzerland. Before that he hold leading positions in QA and QC at CarboGen ( ), Novartis ( ) and Sandoz ( ). Josef worked in various groups of APIC/CEFIC and is specialized in Quality Management Systems. Max Lazar Max graduated from Brooklyn College of the City University of New York where he majored in Chemistry. He retired from Hoffmann-La Roche Inc. in 2001 after 35 years of service. (6) From 1994 to 2001 Max was Vice President, FDA & DEA Compliance, responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals (Solid, Liquid, and Sterile), R&D, Diagnostics, Fine Chemicals and Vitamins. In that position he was responsible for compliance oversight of all of the Roche USA businesses including Active Pharmaceutical Ingredients, Pharmaceuticals, R&D, Diagnostics, Fine Chemicals and Vitamins. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance. As a voting member of the ICH Expert Work Group (EWG) that developed and negotiated this new international standard, Max is uniquely qualified to share and explain the EWG's intent of this new guidance. His involvement in this new API GMP pre-dates the ICH activity itself. His more than 40-year career in the Pharmaceutical Industry includes numerous memberships and chairs of committees. He founded and chaired the Pharma-

7 ceutical Manufacturers Association's Bulk Pharmaceutical Committee of the Quality Control Section. Max was named Topic Leader for the Pharmaceutical Research and Manufacturers Association's (PhRMA) ICH Q7A team that developed the API GMP document for ICH. He represented USA industry at the PIC/S Canberra Conference. Max was named as PhRMA's representative on the FDA PQRI initiative that developed the initial Bulk Substance projects. He was Vice Chair of the USP Pharmaceutical Waters Expert Committee ( ) and has been re-elected to another 5-year term ( ) as a member on this USP Expert committee. For his contribution to Q7A, he was awarded the USA FDA Commissioner's Special Citation For outstanding cooperation and achievement in developing an internationally harmonized good manufacturing practice guidance for active pharmaceutical ingredients used in human drug products. He is a member of numerous professional organizations. He is on the Editorial Board of the Journal of GXP Compliance and has contributed to several books dealing with APIs, and has written and published several guidances covering Bulk Pharmaceutical Chemicals (API) as chair of the PhRMA and PMA Bulk QC Committee and Workgroups. Gordon Munro, Ph.D. Watson Pharamceuticals Inc., USA Gordon has a BSc in Pharmacy and a Masters and PhD in Analytical Chemistry. He is a Fellow of the Royal Pharmaceutical Society (UK) and a Chartered Chemist. Initially Gordon was employed within the pharmaceutical industry by Glaxo for over twenty-five years at various senior positions in research, production and Quality Assurance of both drug substances and drug products among the globe. For seven years Gordon was Director of Inspection and Enforcement Division for the United Kingdom Medicines Control Agency (today MHRA). In June 2004 he joined Watson Pharmaceuticals, Inc. as Senior Vice President of Quality Assurance. Gordon represented the Agency on the PIC/S Committee of Experts, the EMEA Ad Hoc Inspection Working Group and European Regulators at ICH on Q7A as rapporteur and Q9. During his period with the Agency he was Acting Chief Executive for a year and a half. He recently joined the ICH Q10 Expert Working Group as an IGPA Observer, is a member of the ISPE and chair of IFPATma. (7)

Gene Murano, Ph.D. Genentech, USA Gene holds a Masters and doctorate in physiology and protein biochemistry from Wayne State University School of Medicine.

Before joining Genentech in 2000, he served for 21 years in various roles at the FDA, Center for Biologics Evaluations and Research, managing overall research and review actives relevant to

8 Gene Murano, Ph.D. Genentech, USA Gene holds a Masters and doctorate in physiology and protein biochemistry from Wayne State University School of Medicine. He is Vice President of Regulatory, Quality and Compliance Policy and Management Operations at Genentech. Before joining Genentech in 2000, he served for 21 years in various roles at the FDA, Center for Biologics Evaluations and Research, managing overall research and review actives relevant to therapeutic Biotech products. For the last 15 years, he also has served both as an FDA and Industry representative in Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). He served as repporteur of ICH Q6B specifications of Biotech Products. Thomas L. Peither Maas&Peither AG, Germany Thomas studied mechanical engineering at the Technical University of Munich and achieved his Diploma in He is managing director of the publisher Maas&Peither. Before founding the Maas&Peither GMP Publishing in 1999 he worked as consultant in the pharmaceutical industry. The last 14 years Thomas was involved in a various industry projects related to GMP. Thomas is engaged in the ISPE CoP PAT Group, a long term member of ISPE and PDA and is co-publisher of the GMP Manual (8)

PDA 71 Years of Connecting People, Science and Regulation

PDA 71 Years of Connecting People, Science and Regulation 1 I m happy to be here. Bom Dia. Estou feliz por estar aqui. Richard M. Johnson PDA President & CEO since 2009 38 years experience in US and International