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Course

Toronto (Woodbridge)

Date:	Name:	Location
Tuesday, May 11, 2010 9:00 AM TO 4:15 PM (Registration 7:30 AM - 9:00 AM)	PSG Annual Conference 2010	Le Jardin Special Event Centre 8440 Highway 27 Woodbridge, Ontario 905-851-2200
Fees:	Registration Link:	Registration Deadline
PSG Member: $350.00 + $17.50GST = $367.50 Non-Member: $450.00 + $22.50GST = $472.50 Health Canada Fee: $200 + $10.00GST = $210.00	Registration for this course is currently closed.	Monday, May 10, 2010
Course Objective:
38th Annual Pharmaceutical Symposium & Exhibition PSG Annual Conference 2010 - Quality in Today's World Tuesday, May 11, 2010 Le Jardin Special Event Centre, Toronto (Woodbridge), Ontario Registration: 7:30 am – 9:00 am Symposium: 9:00 am – 4:15 pm Exhibition: 9:30 am – 3:30 pm Job Fair: 12:30 pm – 6:00 pm To view the full-colour brochure, CLICK HERE To view the Symposium Agenda, CLICK HERE For a printable Registration Form, CLICK HERE LOCATION: Le Jardin Special Event Centre 8440 Highway 27, Woodbridge, ON L4L 1A6 905-851-2200 lejardin.com ACCOMMODATION: Holiday Inn Express & Suites 6100 Highway 7, Vaughan, ON L4H 0R2 905-851-1510 hiexvaughan.com Registrant accommodation for Monday, May 10, 2010, has been arranged at a special rate of $134.95/night (+ applic. taxes + gratuities). To access the special rate, registrants must reserve accommodation prior to April 19 using the following reservation methods with the booking code PSG or with the party of Pharmaceutical Sciences Group (PSG) Annual Conference 2010: Phone – Call the hotel directly at 905-851-1510, ext. 5512; Email – Send an email to info@hiexvaughan.com – indicate group name, booking code, number of people, arrival/departure date, number of nights, number of rooms and special requests. Online – Visit the following website: http://www.ihg.com/h/d/HI/1/en/rates /YYZWB?groupBookingCode=PSG&_IATAno=99801505 ** Annual Conference Registrants must book their own accommodation.**
Course Description:
The Symposium will provide “world leading specialists” from the U.S. FDA, Health Canada and the Pharmaceutical Industry. Topics of major importance to the Pharmaceutical Industry will be covered. The FDA will address “New QbD Program for Generic Drugs”, as well as “What Companies should do to Avoid Delays in FDA Submission Reviews”. Revisions to the following critical Guidances will be discussed by Health Canada: “Guidance on Drug GMP Compliance of Foreign Sites”; “Revisions to Guidelines for Temperature Control of Drug Products during Storage and Transportation”; and “Changes to the Medical Device Inspection Program”. A Panel discussion by Health Canada presenters will also take place and will be comprised of a Q&A. In addition, a challenging “case study” on “GMP Challenges relating to GMP Compliance and How They Were Resolved” will be presented. As in previous years, the Symposium affords an excellent opportunity to network with business colleagues and government officials. Suppliers from the laboratory, instrumentation and regulatory compliance consulting industries have been invited to exhibit at the Exhibition. For additional exhibitor information, including Exhibitor Registration Form, CLICK HERE EXHIBITION HALL is FREE to everyone (no registration required). PSG will host an Industry mini-JOB FAIR at PSG’s Annual Conference 2010 from 12:30 pm to 6:00 pm. There will be job postings for various functions in different companies. PSG Members are welcome to browse and apply for any of the positions. Please bring copies of your resume, along with a pen, as photocopying services are not available on site. The JOB FAIR is FREE to all PSG Members and Annual Conference registrants. Individuals do not need to register in advance to attend the Job Fair. You will be asked to show your membership card or Annual Conference 2010 name badge at the door. *Membership can be purchased at the Job Fair. Payment will be accepted by "Certified”* cheque, VISA, MasterCard or AMEX. PSG Membership purchased at the Job Fair is valid until August 31, 2011. Please note**: PSG does not assume any responsibility in the hiring process. For additional information on the JOB FAIR CLICK HERE
Course Leader:
PSG Annual Conference 2010 Aloka Srinivasan, Ph.D. - Team Leader, Office of Generic Drugs, Centre for Biologics Evaluation and Research, U.S. FDA - Aloka Srinivasan has been with the Office of Generic Drugs (OGD) since 2003. She is currently a team leader in Division III. She has actively participated in several committees and working groups in OGD, including the Question Based Review (QbR) Working Group. She is also a current member of the USP Expert Committee for Cardiovascular Drugs. Prior to joining OGD, Dr. Srinivasan was a scientist at National Cancer Institute, Frederick Cancer Research and Development Facility of NIH. Her research involved the study of nitric oxide donor as pro-drugs. As a part of her Ph.D. work at University of Missouri, Columbia, she studied methods related to carcinogenic activation of nitrosamines. Dr. Srinivasan has authored numerous peer reviewed publications and holds several patents in her field of research. She has presented on behalf of the agency on numerous occasions regarding the merits of ANDA submissions in QbR-QOS format. Chad Sheehy - Manager, Inspectorate Ontario Operational Centre, Health Canada - Chad Sheehy is the Manager of the Inspectorate Ontario Operational Centre. From 2007-2010, he worked as 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 is the past chair of Health Canada’s Drug GMP Committee (the technical advisory committee) and he represented Canada at the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Committee of Officials. Vincent Tong - Compliance Officer, HPF Inspectorate, Ontario Operational Centre, Health Canada - Vincent has been with Health Canada since 2002. Since that time he has worked with the Biologics and Genetic Therapies Directorate and the Inspectorate. His current position is with the Regions and Programs Branch, Ontario Region, Health Products and Food Inspectorate, Drug Inspection Unit A. Kevin Chin - Medical Device Specialist, HPF Inspectorate, Ontario Operational Centre, Health Canada - Kevin Chin obtained honours B.Sc. in Cell and Molecular Biology at the University of Toronto. Within the Inspectorate, he has worked for the Drug Compliance and Verification Unit and has conducted inspections at the Canadian Blood Services and fertility clinics under the Blood, Tissues, Organ and Xenographs program. For the last fours years he has been the Compliance Specialist in the Medical Devices Inspection Unit for the Ontario Region. He is currently a member of the Medical Device Inspection Committee who is responsible for maintaining the Medical Device Establishment license inspection program and to-date has been directly involved with over 80 inspections. Stuart Wright - Executive Director, CMC & Quality, i3 CanRed Inc. - Stuart has more than twenty five years of pharmaceutical industry experience in Canada and UK, including GlaxoSmithKline, Sandoz, ICI and Organon. He has specific expertise in, Operations Management, Process Improvement and cGMP Compliance Management. He has extensive experience Auditing Manufacturing facilities around the world as part of Due Diligence for our clients. Stuart oversees a large team of CMC, Quality professionals that support each of i3CanReg’s Clinical teams for all global markets. Robert A. Yetter, Ph.D. - Associate Director for Review Management, Center for Biologics Evaluation and Research, U.S. FDA - CBER regulates vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies. Its responsibilities include oversight of the investigational phases of product development, decisions regarding licensure, and post-licensure surveillance activities. Dr. Yetter’s duties involve development and coordination of center review and regulatory procedures, including initiatives stemming from the Food and Drug Administration Amendments Act of 2007. Prior to taking his present position in the Center, as a member of the Office of Vaccines Research and Review, he was responsible for conducting reviews and inspections leading toward approval of biological products. Dr. Yetter received his B.S. from Emory University, his M.S. from Georgia State University and his Ph.D. from the University of Florida. He spent six years at the National Institute of Allergy and Infectious Diseases and four years in the Research Service of the Department of Veteran’s Affairs before joining the FDA.
Who Should Attend:
Anyone involved in regulatory and compliance issues in the pharmaceutical industry.

Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)