2012 Health Products and Food Branch (HPFB) International Regulatory Forum

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Contact: Bureau of Policy, Science and International Programs

September 24-28, 2012
Ottawa, Canada

Day 1 - Monday, September 24^th

08:00 - 08:45

Registration

8:45 - 9:00

Opening Remarks

9:00 - 10:00

Part I: Canadian Regulatory Context

9:00 - 9:30

HPFB and the Canadian Regulatory Environment

9:30 - 10:00

Pharmaceutical/Biologic Regulations and Pre-Market Review Process

10:00 - 10:15

Break

10:15 - 11:45

Part II: Canadian Regulatory Context

10:15 - 10:45

Medical Device Regulations and Pre-Market Review Process

10:45 - 11:15

Natural Health Product Regulations and Pre-Market Review Process

11:15 - 11:45

Panel Question and Answer

11:45 - 13:00

Lunch on your own

13:00 - 14:30

Part I: Regulation of Clinical Trials

13:00 - 13:20

Overview

13:20 - 14:00

Conduct and Assessment

14:00 - 14:30

Medical Device Investigational Testing

14:30 - 14:45

Break

14:45 - 17:00

Part II: Regulation of Clinical Trials 14:45 - 17:00

14:45 - 15:15

Pre-Market Safety Surveillance

15:15 - 16:15

Statistical Analysis of Clinical Trials

16:15 - 17:00

Panel Question and Answer

Day Ends at 17:00 - Return your headset to registration

Day 2 - Tuesday, September 25^th

Day starts at 8:30 - Pick up headsets from Registration (Parallel Sessions All Day)

Biologics

8:30 - 10:00

Vaccine Regulation: Introduction and Submission Screening

10:00 - 10:15

Break

10:15 - 11:30

Vaccine Regulation: Clinical Review Assessment of Submissions

11:30 - 12:30

Lunch

12:30 - 14:15

Vaccine Regulation: Clinical Review, Case Study Examples, Panel Discussion

14:15 - 14:30

Break

14:30 - 17:00

Vaccine Regulation: Quality Review, Vaccine Review Process, Case Study Examples Discussion

Pharmaceuticals

8:30 - 10:00

Part 1: Science and Risk-Based Approach to Product Development and Submission Review

10:00 - 10:15

Break

10:15 - 12:00

Part 2: Science and Risk-Based Approach to Product Development and Submission Review

12:00 - 13:00

Lunch

13:00 - 14:45

New Drugs: Clinical Review

14:45 - 15:00

Break

15:00 - 17:00

Bioequivalence

Medical Devices

8:30 - 10:00

Global Harmonization Task Force (GHTF) Guidances in Medical Devices Program and Launch of International Medical Device Regulators Forum

10:00 - 10:15

Break

10:15 - 12:00

Classification Rules for Medical Devices and In Vitro Diagnostic Devices (IVDD)

12:00 - 13:00

Lunch

13:00 - 14:45

PART 1: Pre-Market Review for Non- In Vitro Diagnostic Devices (Non-IVDD)

14:45 - 15:00

Break

15:00 - 17:00

PART 2: Pre-Market Review for Non- In Vitro Diagnostic Devices

Natural Health Products

8:30 - 10:00

Continuous Improvements at the Natural Health Products Directorate

10:00 - 10:15

Break

10:15 - 11:30

The Life Cycle of a Product License Application for Natural Health Products

11:30 - 13:00

Lunch

13:00 - 14:45

Site Licensing and Good Manufacturing Practices Requirements for Natural Health Products in Canada

14:45 - 15:00

Break

15:00 - 17:00

Pathway to Licensing for Natural Health Products in Canada

Day ends at 17:00 - Return headsets to Registration.

Day 3 - Wednesday, September 26^th

Day starts at 8:30 - Pick up headsets from Registration (Parallel Sessions and Plenary)

Biologics

8:30 - 10:00

Lot Release for Vaccines, Lot Release System in Canada

10:00 - 10:15

Break

10:15 - 12:00

Lot Release for Vaccines, Case Study Examples

12:00 - 13:00

Lunch on your own

13:00 - 14:30

Lot Release for Vaccines, Question and Answer Panel Discussion

14:30 - 15:00

Break and group photo

15:00 - 17:00

Marketed Health Products Program: Canada Vigilance

Pharmaceuticals

8:30 - 10:00

Part 1: Generic Drug Review: International Collaboration

10:00 - 10:15

Break

10:15 - 12:00

Part 2: Generic Drug Review: International Collaboration

12:00 - 13:00

Lunch on your own

13:00 - 14:30

Joint Session for Pharmaceuticals and Medical Devices, Health Technology Assessment

14:30 - 15:00

Break and group Photo

15:00 - 17:00

Marketed Health Products Program: Canada Vigilance

Day ends at 17:00 - Return headsets to Registration

Medical Devices

8:30 - 9:45

Pre-Market Review for In Vitro Diagnostic Devices - Case Study (IVDD)

9:45 - 10:00

Break

10:00 - 12:00

Quality Management Systems, Registrars, Auditing and the Medical Device Single Audit Program

12:00 - 13:00

Lunch on your own

13:00 - 14:30

Joint Session for Pharmaceuticals and Medical Devices, Health Technology Assessment

14:30 - 15:00

Break and group photo

15:00 - 17:00

Marketed Health Products Program: Canada Vigilance

Day ends at 17:00 - Return headsets to Registration

Natural Health Products

8:30 - 10:00

Natural Health Products - Online Solution Systems

10:00 - 10:15

Break

10:15 - 12:00

Natural Health Products - Interfaces in Classification

12:00 - 13:00

Lunch on your own

13:00 - 14:30

Managing Incidents of Risk for Natural Health Products

14:30 - 15:00

Break and group photo

15:00 - 17:00

Marketed Health Products Program: Canada Vigilance

Day ends at 17:00 - Return headsets to Registration

Day 4 - Thursday, September 27^th

Day starts at 9:00 - Pick up headsets at registration

9:00 - 9:30

Introduction to HPFB Inspectorate

9:30 - 10:30

Quality System Framework

10:30 - 10:45

Break

Option

10:45 - 11:30

Mutual Recognition Agreement

or

10:45 - 11:30

The Border Integrity Program

11:30 - 13:00

Lunch on your own

13:00 - 13:30

Establishment Licensing Process; and

Option

13:30 - 15:00

Good Manufacturing Practices

or

13:00 - 14:00

Anti-Counterfeit Panel; and

14:00 - 15:00

Overview of Medical Device Regulations

15:00 - 15:15

Break

Option

15:15 - 16:45

Good Manufacturing Practices Continued

or

15:15 - 16:45

Medical Device Inspections

• Domestic
• Foreign

Day ends at 16:45 - Return headsets to Registration

Day 5 - Friday, September 28^th

Day starts at 9:00 - Pick up headsets at registration

Option

9:00 - 10:00

Good Clinical Practices

or

9:00 - 10:00

Cells, Tissues and Organs Registration; Cells, Tissues and Organs Inspection Program Overview

10:00 - 10:15

Break

Option

10:15 - 11:15

Good Clinical Practices continued; and

11:15 - 12:00

Laboratory Program

or

10:15 - 12:00

Drug Compliance Verification and Investigation

12:00 - 13:30

Lunch on your own

13:30 - 14:30

Screening for Undeclared Ingredients; Testing of Epipens

14:30 - 15:30

Director General Question and Answer Panel; Closing Remarks

Day ends at 15:30 - Return headsets to registration