SHOWS & EVENTS |
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Blueprint for change:
The evolving regulatory environment for
pharmaceuticals in Canada
Drug Information Association’s 5th Canadian Annual Meeting
 Co-chairs: Rav Kumar, PhD, Vice President, Pharmaceutical R&D/ Regulator y Affairs, GlaxoSmithKline, Canada / Supriya Sharma, MD, MPH, FRCPC - Acting Director General, Therapeutic Products Diirectorate, Health Canada |
In the past, the focus with respect to pharmaceutical products has been on health protection. Regulation of drugs has concentrated on identifying and preventing safety risks. Today, however, the pharmaceutical industry and government are under increased public scrutiny to identify and disclose all the significant information about drug benefits and risks. In response, the Drug Information Association (DIA), in collaboration with Health Canada, will discuss the important issues facing Health Canada, the pharmaceutical industry, academics, and other areas of the health sector and the healthcare system at the 5th Canadian Annual Meeting (October 28-30; Ottawa, Ontario, Canada).
The Canadian Annual Meeting has grown significantly over the past two years — with industry presence increasing annually. This year features representation not only from Health Canada but also from several major pharmaceutical companies, including Amgen, GlaxoSmithKline, and Novartis; smaller industry and biotechnology companies; and various Canadian CROs.
Rav Kumar, PhD, Vice President, Pharmaceutical R&D/Regulatory Affairs, GlaxoSmithKline Canada and Supriya Sharma, MD, MPH, FRCPC, Acting Director General, Therapeutic Products Directorate, Health Canada, will co-chair a program featuring topics on:
- Health Canada’s progressive licensing Project;
- Risk management and safety signal detection;
- Sustainability of Canada’s healthcare system;
- Public demand for more information and greater transparency;
- Growth of biosimilars and second-entry biologicals in Canada;
- Application of technology to the development and regulation of pharmaceutical products.
“The expectations of Canadians for transparency, openness, increased information, and a regulatory system that supports access to the drugs that can help them maintain and improve their health, must be addressed,” said Dr Sharma. “The Canadian Annual Meeting provides the perfect forum for representatives from industry, academia, and government to discuss the challenges facing all Canadians”.
The program agenda for the 5th Canadian Annual Meeting will include, but not limited to:
- Progressive licensing framework;
- Sustainability of performance;
- eSubmissions and other electronic technology;
- Risk management;
- Clinical trials registries;
- Clinical research and clinical trials;
- National pharmaceutical strategy;
- Common Drug Review (CDR);
- Manufacturing “quality by design” and CMC for the 21st century;
- Canadian Environmental Protection Act;
- Current issues in bioequivalence;
- Signal detection;
- Ethics in clinical trials and emerging technologies;
- Pharmacogenomics and pharmacovigilance;
- Generic drug issues (biosimilars and second entry biologicals).
For more program information log on to the DIA website:
www.diahome.org and click on the 5th Canadian Annual Meeting link
About the Drug Information Association
The Drug Information Association serves more than 18,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and life cycle management processes. Headquartered in Horsham, Pa, USA, and with offices in Basel, Switzerland and Tokyo, Japan, the Association is led by its volunteer-based board of directors and executive management team. For more information, visit www.diahome.org or call 215-442-6100.
