↓ More Below ↓

Regulatory Strategies for Natural Health Products

ONE AND A HALF DAY COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
Receive a Credit toward the Diploma program in Professional Regulatory Affairs

Register online Download Registration Form (PDF)
Request more information

Distinguished Faculty

Dr. Mary Mazur-Melnyk
Chief Scientific Officer
Innovalinks

Dr. Mary Mazur-Melnyk was educated in Toronto and holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. She brings to the table over 20 years of experience in Biologics, Medical Devices and Biopharmaceutical industries. She has held senior level position in the areas of Regulatory Affairs and Quality Assurance at Aventis Pasteur, GSK, Novartis and most recently for Biovail Corporation as their Corporate Vice President of Quality. Currently, she is a Senior Partner with Innovalinks Quality Consultants (IQC), which specializes in the areas of Regulatory and Quality systems. She has extensive experience in the areas of technology transfer, R and D streamlining, and global regulatory approvals of NCEs.


Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

Dates Available

September 22-23, 2011

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $885.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Abstract

Under Canadian Regulations, natural health products (NHPs) are defined as:

NHPs must be safe for consideration as over-the-counter products, be available for self-care and self-selection and not require a prescription to be sold.

This course is designed to help you navigate these new regulations, interact with the NHP directorate and successfully bring an NHP to the market.

Course Outline

  1. Natural Health Products – an overview
    1. Scope of the NHP regulations
    2. Product classifications
  2. Main Components of the NHP regulations
    1. Product licensing
    2. Site licensing
    3. Good manufacturing practices
    4. Labelling and Packaging
  3. Other Activities covered under the NHP regulations
    1. Importing for sale in Canada
    2. Distribution
    3. Clinical Trials
    4. Adverse Event Reporting
  4. Comparison with regulations in other jurisdications
    1. US
    2. EU
    3. Australia/New Zealand

Two Workshops

Each Day concludes with a workshop

Who Should Attend

This Two day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:

Agenda - Day One

8:30 am - 9:00 am
Registration and Continental Breakfast

9:00am – 9:05am 
Opening Remarks

9:05am -10:45am 
Regulatory Strategies for Natural Health Products Begins

10:45am -11:00am 
Mid-Morning Break

11:00am – 12:45pm 
Regulatory Strategies for Natural Health Products Cont'd

12:45pm -1:45pm 
Luncheon

1:45pm – 3:30pm 
Workshop

3:30pm – 3:45pm 
Afternoon Break

3:45pm – 5:00pm 
Workshop

Agenda - Day Two

9:00am -10:45am 
Regulatory Strategies for Natural Health Products Begins

10:45am -11:00am 
Mid-Morning Break

11:00am – 1:00pm 
Regulatory Strategies for Natural Health Products Cont'd

Technological/Computer Requirements: N/A


Certificate of Attendance and Course Material