Agenda

Day 1 Oct 26, 2015

7:30 AM — 8:30 AM

Morning Tutorial Registration

8:30 AM — 12:00 PM

Tutorial #1 - Plain Language Labeling: Implementing Health Canada's Guidance for Industry

12:30 PM — 1:30 PM

Afternoon Tutorial Registration

1:30 PM — 5:00 PM

Tutorial #2 - Strategies for Efficient Submission Preparation

Day 2 Oct 27, 2015

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 8:40 AM

Opening Remarks

8:40 AM — 9:10 AM

Rare Diseases in Canada; Diagnostic Therapeutic and Regulatory Challenges

9:10 AM — 10:30 AM

Session 1 Plenary Session: New Era of Regulatory Affairs – Part I

10:30 AM — 11:00 AM

Refreshment Break

11:00 AM — 12:15 PM

Session 2 Plenary Session: New Era of Regulatory Affairs – Part II

12:15 PM — 1:30 PM

Lunch

1:30 PM — 3:00 PM

Session 3 Track A - Regulatory Leadership: The Importance of a Timely and Efficient Regulatory System and a Proposed Path for Success

1:30 PM — 3:00 PM

Session 3 Track B - Labeling and Advertising and Promotion: Implementation of Health Canada’s revised Guidance for Industry: Review of Drug Brand Names

1:30 PM — 3:00 PM

Session 3 Track C - Clinical Practice: DIA Adaptive Design Scientific Working Group Best Practices Team: Objectives and Case Studies

3:00 PM — 3:30 PM

Refreshment Break

3:30 PM — 5:00 PM

Session 4 Track A - Transparency and Oversight: Premarket Transparency in the Review of Health Products

3:30 PM — 5:00 PM

Session 4 Track B - Regulatory Information and Data Standards: Recent Trends in Regulatory Information Standards

3:30 PM — 5:00 PM

Session 4 Track C - Pharmacovigilance and Risk Management: Safety Surveillance of Scientific Literature for Medical Devices, Drugs, and Combination Products

5:00 PM — 6:00 PM

Networking Reception

Day 3 Oct 28, 2015

7:30 AM — 8:30 AM

Registration and Continental Breakfast

8:30 AM — 10:00 AM

Session 5 Track A - Regulatory Leadership: Challenges with Increasingly Smaller and Specific Patient Populations in Oncology

8:30 AM — 10:00 AM

Session 5 Track B - Regulatory Information and Data Standards: Regulatory Information and Data Standards for Improved Health Product Safety

8:30 AM — 10:00 AM

Session 5 Track C - Science, Quality, and Good Manufacturing Practices: Good Manufacturing Practices: Compliance Trends and Initiatives

10:00 AM — 10:30 AM

Refreshment Break

10:30 AM — 12:00 PM

Session 6 Track A - Transparency and Oversight: Postmarket Transparency for Health Products

10:30 AM — 12:00 PM

Session 6 Track B - Labeling and Advertising and Promotion: The Product Monograph Project

10:30 AM — 12:00 PM

Session 6 Track C - Pharmacovigilance and Risk Management: Pharmacovigilance Systems/Models and eReporting

12:00 PM — 1:30 PM

Lunch

1:30 PM — 3:00 PM

Session 7 Plenary Session: International Update

3:00 PM — 3:00 PM

Meeting Adjourns

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DIA Annual Canadian Meeting 2015

Agenda

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