December 5, 2011
Montréal, QC

Event participants:

Antoine Aylwin, Julie Desrosiers, Lucie Dufour, Hilal El Ayoubi, Mathieu Gagné, Serge Lapointe, Ph.D.

8:30 a.m. – 8:45 a.m.
Introduction and Overview of the Training Day

8:45 a.m. - 9:45 a.m.
Protection of personal information in a pharmaceutical company
Antoine Aylwin, Fasken Martineau
a) Employees
b) Service providers
c) Physicians
d) Volunteers/Patients (involved in research and development)
e) Consumers

9:45 a.m. – 11:00 a.m.
New developments and last tendencies in pharmaceutical regulations in Canada
Mathieu Gagné, Fasken Martineau
a) Extended role of pharmacists – The Super Pharmacists
b) Drug Dispensing Machines – Green Light in Ontario
c) Assessing changes in pricing and reimbursement in Canada
d) DTC Advertising

11:00 a.m. – 11:15 a.m. Coffee break

11:15 a.m. – 12:15 p.m.
Drafting and negotiating of agreements for pharmaceutical companies
Lucie Dufour, Fasken Martineau
a) Different types of Agreements: different considerations/objectives but same concerns
b) Critical provisions and issues

12:15 p.m. – 12:30 p.m.
Update on Ongoing Projects and Regulatory Trends at Health Canada
Mathieu Gagné, Fasken Martineau
a) Review of the regulatory framework on clinical trials
b) Harmonization of REB standards and assessment procedures
c) Summary basis of decision project
d) Good Manufacturing Practices for cosmetics
d) Etc.

12:30 p.m. – 13:30 p.m. Lunch

1:30 p.m. – 2:45 p.m.
Latest developments and case studies related to
pharmaceutical patent litigation in Canada
Julie Desrosiers, Fasken Martineau
Hilal El Ayoubi, Fasken Martineau

2:45 p.m. – 3:45 p.m.
What you need to know with respect to Patent exclusivity and life cycle management of pharmaceuticals
Serge Lapointe, Fasken Martineau
a) Review of non-patent drug exclusivities available in the US, CA and EU;

3:45 p.m. – 4:00 p.m. Coffee Break

4:00 p.m. – 4:45 p.m.
Case law review on pharmaceutical regulations in Canada
Mathieu Gagné, Fasken Martineau
a) Case law review in the pharmaceutical industry from the conception of a drug until its consumer use
b) Impacts and particularities of litigation cases involving the pharmaceutical industry
c) Main outcomes resulting from those case laws

4:45 p.m.
Summary of the day and end of the Training Day