Thursday September 2, 2010 Thursday September 2, 2010
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Mr. Roy Thaller
Acting GMP Manager
Health Canada |
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Roy Thaller graduated from the University of British Columbia with a B.Sc. in Microbiology in 1978 and an M.Sc. in Pharmaceutical Sciences in 1980. Later in he completed an M.B.A. in 1986. Since 1980, Roy has worked in quality control, quality assurance, and quality systems with MDS Nordion in Vancouver and Ottawa and Redcross/Canadian Blood Services. He joined Health Canada in 2000 and has worked in the Biologics and Genetic Therapy Directorate and Inspectorate - GMP Unit in Ottawa.
Roy moved back to Vancouver in 2006 to be Supervisor, Inspections and Investigations for Western Operational Center. Roy is currently acting as the manager of the GMP Unit in Ottawa.
Mr. Ian Holloway
Head of the Defective Medicines Report Center
Medicines and Healthcare Products Regulatory Agency (MHRA) |
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Mr Ian Holloway is manager of the UK Defective Medicines Report Centre for the MHRA (UK Regulatory Agency) located in London. The centre liaises with manufacturers, distributors, hospitals and pharmacies to direct recalls, issue timely notifications and oversee corrective actions for confirmed and suspected medicine defects.
He is a registered Pharmacist and has post-graduate qualifications in Pharmacology and Business Studies. He previously worked for the MHRA for over ten years as a site inspector for Good Manufacturing Practice and Good Distribution Practice at sites in the UK and worldwide. Prior to joining the Defect Centre he worked for the Agency as a Pharmacovigilance inspector and helped establish a new system of site Pharmacovigilance inspection systems.
Dr. Wallace Lauzon
Senior Biologist/Evaluator Cytokines Division, CERB BGTD
Health Canada |
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Dr. Wallace Lauzon obtained his Ph. D. in Microbiology and Immunology at the University of Ottawa. Prior to arriving at Health Canada, he did post-doctoral work at the Ottawa Health Research Institute in the immunobiology of HIV treatment and in vaccine development. He joined the Biologic and Genetic Therapies Directorate (BGTD) in 2001 as a Chemistry and Manufacturing reviewer in the Biotherapeutics Division. He has extensive evaluation experience with a wide range of biotherapeutic products including some traditional biologics. He is currently a senior evaluator with the Cytokines Division in the Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB) where his responsibilities include chemistry and manuufacturing pre-market assessment, leading on-site evaluations, laboratory supervision and lot release for Biotherapeutic products.
Dr. Ali A. Mohammadi, DVM, MSc, PhD
Scientist, Biosafety
Laboratory Alliance and biosafety International Health Regulations World Health Organization |
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Dr. Mohammadi has spent most of his career in combating communicable diseases either directly managing such programs or indirectly through the following activities:
On the national level:
On the international level, Dr Mohammadi has been involved in development and negotiations of three International Conventions namely:
During the negotiations on BiologicalWeapons Convention in the United Nations, Geneva, he has been the Vice-chairman of the UN AD HOC Group for negotiations on destruction and prohibition of Biological Weapons and the chairman of one important part of the negotiation i.e. Definitions of terms and Objective criteria such as list of biological agents, dual use laboratory equipment and threshold quantities for more than ten years. During these negotiations he was able to manage and run this controversial issues between delegations from 134 member States in such a way while trying to move the discussion forward also avoid any conflicts between delegations and political groups.
Mr. Mohammadi was involved in the negotiations on CWC in Geneva, the Hague and was a member of the Scientific Advisory Board. As the Director of the Department of Environmental Damage Assessment, Mr. Mohammadi was involved in the negotiations in regards to the development of the protocol of Access and Benefit Sharing ABS for genetic resources as the Chairman of the Group of 77+ China in Bon, Germany.
Because of successful operation of these tasks, Dr Mohammadi was then nominated and received the Golden Medal and Charter of Humanism by International League of Humanists, Philadelphia, USA which was given to me in Sarajevo, Bosnia in 1998.
Activities in WHO:
Dr. Sonya Agbessi
Evaluator of GMP Establishment License Application for Natural Health Products
NHPD, HPFB Health Canada |
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Dr. Agbessi obtained her PhD in biology (microbiology) from the "Université de Sherbrooke" and then, worked as a research scientist in a biotechnology company in Montreal. She joined the NHPD in 2005 where she is a GMP evaluator of site licence applications submitted by Canadian manufacturers, packagers, labellers and importers. She also acted as Head of the Site Licence Assessment Unit with the Bureau of Product Review and Assessment at the NHPD.
Mr. Mark Elengold
President
FDA Strategies LLC |
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Mr. Mark A. Elengold is President of FDA Strategies LLC, which provides consulting services to FDA regulated industry and the financial community. He retired as the Deputy Director of the FDA’s Center for Biologics Evaluation and Research, after thirty-four years of service. He is an expert and frequent speaker on regulatory and compliance activities, Good Manufacturing Practices (GMPs), and FDA application review procedures, including electronic submissions. After receiving a B.A. from Queens College of the City University of New York in 1971, he served as an FDA investigator in the New York District Office and the White Plains Resident Post. Prior to joining CBER in December, 1988, he held various positions in the Center for Drug Evaluation and Research, the Bureau of Veterinary Medicine and the Office of the Commissioner. He received many Department of Health and Human Services and FDA awards, including the Secretary’s Distinguished Service Award, the Surgeon General’s Exemplary Service Award, the FDA Distinguished Career Service Award, several FDA Awards of Merit, and a Commissioner's Special Citation.
Mr. Ian Grimwood
Border Integrity Specialist
Emergency Preparedness Unit Health Canada |
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biography to be posted.
Ms. Manon Parent
Border Integrity
Emergency Preparedness Specialist Health Canada |
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Health Canada's mission is to help the people of Canada maintain and improve their health. With that mission in mind, the Health Products and Food Branch (HPFB)'s mandate is to take an integrated approach to managing the health-related risks and benefits of health products and food by: minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and, promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.
Responsibility of Border Integrity/Emergency Preparedness Specialist: Regional implementation of the Inspectorate’s National Border Integrity program to manage the safety and health risks posed to Canadians by non-compliant health products. Participation in the development of national strategies, plans, collaborative relationships and training programs to support border integrity, anti-counterfeiting, and emergency preparedness initiatives. Provision of technical expertise to Operational Centre management and staff, and to external compliance/enforcement organizations operating in the region.
Dr. Michael Schunk DVM, DVSc
Senior Director Bulk Manufacturing
Sanofi-Pasteur |
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Dr. Schunk, is the Senior Director of Bulk Manufacturing at Sanofi-pasteur, located in Toronto, Canada. He is responsible for viral and bacterial active ingredient manufacturing operations in multiple facilities on a large vaccine manufacturing and research site in Toronto. The manufacturing occurs under cGMP for US, Canadian, European, Japanese and world markets. Dr. Schunk, has over 13 years of experience in the biological industry. Previous positions have included Director of Quality Control at the Toronto site and Senior Director of Quality Control and Material Quality overseeing a staff of 300 at Aventis Pasteur, France.
Dr. Schunk degrees are; Doctor of Veterinary Medicine and Doctor of Veterinary Science in Pathology
Mr. Dominique Jeandupeux
Director of Scientific Affairs
Stiefel, a GSK company |
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Mr. Dominique Jeandupeux has nineteen years of experience at Stiefel where he developed expertise in clinical research, post market safety surveillance, medical communication, product development, quality assurance and mainly in regulatory affairs. He establishes regulatory strategy and operational excellence for optimal success during all aspects of pre and post approval phases for dermatological drugs, natural health products, medical devices and cosmetics. In addition, he oversees the activity of the quality assurance group at Stiefel.
Before joining the industry, Dominique conducted experiments in the field of cardiac arrhythmia at McGill University. He holds a Master’s degree in neurophysiology from McGill along with numerous training in pharmaceutical industry and dermatology related topics.
Dominique is currently Director Scientific and Regulatory Affairs at Stiefel in Montreal.
Ms. Janike Pitre
Mutual Recognition Agreement (MRA) Officer
Health Canada |
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Janike has been working for Health Canada since 1992. She began as a Laboratory Analyst, than worked as a Drug Inspector, a BTOX (Blood, Tissue, Organ and Xenograft) Specialist and as a Quality Assurance Auditor. She is now a Mutual Recognition Agreement Officer and she is reporting to the Inspectorate Quality and International Assessment Division Manager.
As a Drug Inspector, she has been conducting GMP inspections and investigations of Canadian manufacturers. As a BTOX Specialist, she has been widely involved in the development and implementation of a BTOX program within the Inspectorate, which includes inspection of Blood establishments according to the GMP Regulations and inspection of Semen establishments according to the Semen Regulations. As a Quality Assurance Auditor, she has been involved in the development and implementation of the Inspectorate Quality System as per the ISO 9002:1994 and ISO 9001:2000 standards, as well as in the conduct of internal quality audits as per ISO 9000 and ISO 17025. Finally, as a MRA Officer, she is now responsible for evaluating the GMP Compliance Programmes of MRA Countries as part of the Confidence Building Phase of the Agreements, and to look after the maintenance of the MRA equivalency between Canada and its partners.
She has a Bachelor degree in Biochemistry and a Master degree in Toxicology. In addition, she is currently in the process of completing a second Master degree in Public Administration.
Mr. Michael Hovey
Director of Quality Management
Janssen-Ortho Inc. |
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Mr. Hovey is currently the Director of Quality Management, Janssen-Ortho Incorporated. Mr. Hovey is responsible for all Quality functions pertaining to the importation and distribution of Johnson & Johnson’s pharmaceutical and biotechnology products. He has taken part in the Johnson & Johnson Global Pharmaceuticals Market Quality Leadership Team and has co-chaired for Johnson & Johnson’s North America Pharmaceuticals & Diagnostics Quality Council, and for the Pharmaceuticals Global Quality Operating Group (GQOG).
Mr. Hovey is a professional with over 20 years of experience. He started his career at Proctor and Gamble as a Group Quality Manager where he was responsible for the Quality Assurance and Compliance of the Health & Beauty care contract manufacturing and importation.
Mr. Eric Parent
Supervisor, Blood, Tissues and Medical Devices Unit
Santé Canada / Health Canada/ HPF Quebec region |
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Mr. Eric Parent is the Supervisor of the Blood, Tissues and Medical Devices Unit for the Quebec Operational Center located in Longueuil. The Food and Therapeutic Products programs and directorates are represented regionally through their compliance verification, investigation, inspection and policy development activities. Both directorates also have a major laboratory component, which makes them highly involved partners at the national level.
Mr. Parent is a chemist who graduated from the "Université du Québec à Chicoutimi (UQAC)" and has worked many years in the Compliance department of a private pharmaceutical company in Montreal. He has joined Health Canada in 2006 as a Medical Devices Inspector.
M. Eric Parent est le Superviseur de l’unité du sang, tissus et instruments médicaux du centre opérationnel du Québec basé à Longueuil. Les programmes/directions des aliments et des produits thérapeutiques sont présents en région par le biais de fonctions de vérification de la conformité, d’enquêtes, d’inspection et d`élaboration des politiques. Ces deux directions ont également un important volet laboratoire qui en font des partenaires très impliqués au niveau national.
M. Parent est un chimiste ayant gradué de l’université du Québec à Chicoutimi (UQAC) et a travaillé plusieurs années dans le département de la Conformité d’une compagnie pharmaceutique privée de Montréal. Il s’est joint à Santé Canada en 2006 en tant qu’Inspecteur aux instruments médicaux.
| Day 1 - Thursday, September 24, 2009 | |||
| 08:00 AM - 08:30 AM | Registration and Continental Breakfast | ||
| 08:30 AM - 08:45 AM | Day One - Chair’s Opening Remarks | ||
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Mr. Dominique Jeandupeux Director of Scientific Affairs Stiefel, a GSK company |
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| 08:45 AM - 09:45 AM | GMPs and Related Requirements | ||
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Mr. Mark Elengold This session will cover the evolution of GMPs in the U.S. from their inception in the 1962 amendments to the Federal Food, Drug and Cosmetic Act to the current quality systems inspection programs and the adoption of ICH Guidances. The initial GMPs and the intensified drug inspection program (GMPs)
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| 09:45 AM - 10:30 AM | The New GMPs | ||
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Mr. Roy Thaller An overview of the major changes to the 2009 edition of Health Canada’s Good Manufacturing Practices Guidelines will be presented along with an explanation of anticipated future changes, in consideration of European and PIC/s requirements. Timelines for implementation will also be covered. |
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| 10:30 AM - 10:45 AM | Mid-Morning Refreshment Break | ||
| 10:45 AM - 11:30 AM | A MHRA Regulator's Perspective and Updates on GMPs: "Perspective on GMP regulation and guidance" | ||
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Mr. Ian Holloway
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| 11:30 AM - 12:30 PM | Update on the Mutual Recognition Agreement (MRA)  |
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Ms. Janike Pitre HPFBI Mutual Recognition Agreement (MRA) Evaluations This presentation will provide an overview of the HPFBI MRA Evaluation process as well as an update on the current situation. |
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| 12:30 PM - 01:45 PM | Luncheon |
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| 01:45 PM - 03:00 PM | WHO Guidelines for Inspection of Biological and Biotechnological Facilities | ||
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Dr. Ali A. Mohammadi WHO has prepared several documents offering guidance for good manufacturing practices (GMP) which describe the compendial and other internationally adopted recommendations with reference to the manufacture and quality control of pharmaceuticals including biological products. Based on these recommendations, WHO has also developed guidelines for inspection of Biological and Biotechnological facilities. This Guide for Inspections presents the necessary requirements in a form which can be used for determining whether a manufacturer complies with the GMP recommendations, as well as serving as an aid in interpreting and clarifying the GMP documents. It is also intended to support harmonization of inspection and internal audit procedures. The audit items in each section are presented first as a list of topics with reference to the relevant WHO GMP clause(s), followed by questions formatted in checklists. The questions are concerned with the various aspects of the facility’s compliance with GMP. The checklists can be used in the planning of or preparation for an inspection and are designed to be duplicated and used during the inspection process, both as an aide memoire and as a record of the observations on which to base the inspection report. Although comprehensive, this series of questions is not exhaustive of all aspects related to GMP inspections of a biological manufacturer. There might be additional aspects which should be addressed for a specific vaccine or biological production process. Overall, responses to groups of questions rather than any single one may, in fact, better reflect actual compliance with good manufacturing practices. The document is not intended to set a minimum level of compliance or an acceptable standard for manufacturers. The response to any findings is left to the discretion of inspector and the national control authorities. The aim is, rather, to increase understanding and implementation of compliance with GMP by manufacturers globally. Using this guide as a tool, it is possible that areas for improvement may be more easily identified and monitored by the national control authority and the manufacturer in the joint task of improving the quality of biological products. The guide will also be of value to manufacturers for internal audits and to national control authorities responsible for carrying out inspections, as well as for evaluations for WHO or other organizations. The document is intended to be equally applicable to the evaluation of facilities in developed and developing countries. This document may also aid in training in GMP and related activities. 1. Personnel, 2. Premises, 3. Equipment 4. Production and In-Process Control, 5. Laboratory Control by Quality Control Laboratories, 6. Documentation of Processing and Distribution, 7. Animals: Quality, Premises and Care, 8. Quality Assurance, 9. Labelling, Packaging and Distribution, 10. Containment practices, and 11. Sanitation and cleaning |
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| 03:00 PM - 03:15 PM | Mid-Afternoon Refreshment |
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| 03:15 PM - 04:00 PM | Revisions to Annex 2 to the GMP Guidelines: Good Manufacturing Practices for Schedule D (Biological) Drugs | ||
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Dr. Wallace Lauzon The GMP annex for Schedule D (Biological) Drugs has recently been revised and will soon be posted for consultation. The revisions to this annex were proposed, in part, to address trends observed during On-Site Evaluations (OSE). The OSE is an integral part of the pre-market assessment process for Biologics. To provide context for the proposed changes to the annex, the role of On-Site Evaluations in the pre-market assessment process and the current trends in the issues encountered during OSEs will be discussed. |
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| 04:00 PM - 05:00 PM | Health Canada Inspectorate: Border Integrity Program |
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The majority of health products on the Canadian market are imported. The impact of this trend on import safety is a cause for concern among Canadians. This concern is heightened by the potential for diverted, unlicensed or counterfeit health products that could enter the Canadian market. The creation of a National Border Integrity program will strengthen Health Canada's ability to make and support admissibility decisions at the border as they relate to health products.
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| 05:00 PM - 05:30 PM | Panel Discussion Q&A Session |
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| 05:30 PM | Conclusion of Day One |
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| Day 2 Friday, September 25, 2009 | |||
| 08:00 AM - 08:30 AM | Continental Breakfast |
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| 08:30 AM - 09:15 AM | Day Two - Chair’s Opening Remarks | ||
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Dr. Michael Schunk DVM, DVSc Perspective from manufacturing: 8 strategies for executing good biologics manufacturing practices Manufacturing under cGMP in a global context introduces layers of laws, regulations, guidance, policies and other prescriptive documents not found in many other industries. This session explores 8 key elements to successfully manage production in such an environment, from the viewpoint of the biological organization.
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| 09:15 AM - 10:15 AM | An overview of the Canadian Medical Devices Regulations will be presented along with a brief description of current initiatives, international cooperation, challenges and future developments related to the medical devices. La présentation sera un aperçu de la règlementation canadienne sur les instruments médicaux ainsi qu’une brève description des initiatives en cours, de la coopération internationale, des défis et développements futurs reliés aux instruments médicaux. |
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Eric Parent |
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| 10:15 AM - 10:30 AM | Mid-Morning Break |
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| 10:30 AM - 11:30 PM | A MHRA Regulator's Perspective and Updates on GMPs: "GMP issues in manufacturing and distribution" | ||
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Mr. Ian Holloway
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| 11:30 AM - 12:30 AM | Industry Considerations and Challenges with Respect to the New GMP’s | ||
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Mr. Michael Hovey
General questions for Industry and Health Canada consideration |
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| 12:30 PM - 01:45 PM | Luncheon |
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| 01:45 PM - 02:30 PM | NHPD Updates |
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Dr. Sonya Agbessi
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| 02:30 PM - 03:15 PM | ICH Guidance and GMPs | ||
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Mr. Mark Elengold (former FDA) This session cover the history, process and current status of the ICH Quality Guidances, particularly Q8, Q9 and Q10 and the concept of "Quality by Design". |
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| 03:15 PM - 03:30 PM | Mid-Afternoon Refreshments |
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| 03:30 PM - 04:30 PM | WHO's perspective on GMP and Biosafety in Vaccine and Other Biopharmaceutical Facilities, Synergies and Conflicts | ||
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Dr. Ali A. Mohammadi WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization” (ref 27). GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints. The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled - controlling the quality of the facility and its systems, controlling the quality which include, of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labelling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process. WHO also defines a different dimension of working with biological agents in laboratories and production facilities namely Biosafety and Biosecurity. In this concept, Laboratory Biosafety is defined as: The containment principles, technologies and practices that are implemented to prevent the unintentional exposure of personnel, process and product to pathogens and toxins, or their accidental release to the environment. Laboratory Biosecurity is also defined as: Institutional and personal security measures, adopted in laboratories, designed to increase the protection and accountability, and to prevent unauthorized access to and the loss, theft, misuse, diversion or intentional release, of valuable biological materials (VBM). There are however, synergies and conflicts in implementation of GMP and Biosafety principle and practices. These include, Physical structure, access management, air control system and operation. |
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| 04:30 PM - 05:15PM | Panel Discussion Q&A Session |
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| 05:15 PM | Conclusion of the Conference |
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