Training

We offer education seminars, presentations and work groups to educate you, your employees and others who require a knowledge base of scientific and regulatory issues. Dicentra’s scientific and regulatory experts can visit your company and provide an on-site training session. We also regularly host online training seminars (listed below) and free regulatory updates every 3 months.

Expanding Your Market to Canada: Opportunities and Obstacles Revealed
Wednesday, April 28, 2010

Classification of Products at the Cosmetic-Drug Interface: a Deeper Look
Wednesday, May 26, 2010

Good Manufacturing Practices Training for Natural Health Product Site License Holders
Wednesday, July 28, 2010



Expanding Your Market to Canada: Opportunities and Obstacles Revealed
Wednesday, April 28, 2010, 1:00 PM Eastern Time
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60 minutes followed by a 30 minute question and answer period
Anne Wilkie & William Morkel
1 Certificate of Course Completion issued to the attendee, and archive of the PowerPoint and audio to keep forever

Nutrition and supplement use is an everyday part of Canadian lives. Today 71% of Canadian adults report that they have used a natural health product, and 38% report that they use at least one on a daily basis. With a population roughly one tenth the size of the U.S., setting foot in this marketplace could easily result in a 10% growth of sales.

Entering the Canadian market, however, is not easy. Unlike the U.S. regulatory landscape, where dietary supplements are monitored post-market, Canada requires products to be licensed prior to market entry by the Natural Health Products Directorate (NHPD), a branch of Health Canada.

This seminar will provide attendees with a step-by-step procedure for bringing dietary supplements to market. Topics covered include:

• an overview of the Canadian natural health product market (prevalence of use and most popular product categories);
  
• a summary of the Natural Health Product Regulations and their implications for companies entering the Canadian market;
  
• labeling requirements and how they differ from U.S. requirements;
  
• a step-by-step outline of all regulatory requirements for entering the Canadian market (product licenses and site licenses for importation);
  
• enforcement measures at the Canadian-U.S. border for natural health products; and,
  
• possible compliance and enforcement measures to be adopted by Health Canada in the near future and the implications on business.
  

This seminar is being presented by Anne Wilkie and William Morkel.

Anne Wilkie is the former Vice President and Head of Regulatory Affairs for the Canadian Health Food Association, Canada's largest trade association representing the interests of retailers and suppliers of natural products and organics. Anne held this role for the past 10 years during which time she developed and led the regulatory program for the CHFA and was actively involved in the creation and implementation of the Natural Health Products Regulations and consultations on the Organic Products Regulations. Prior to the CHFA, Anne worked for Health Canada and the Canadian Food Inspection Agency in a variety of roles including Laboratory Analyst, Food and Drug Inspector and Nutrition Program Specialist.

William Morkel, Senior Regulatory Affairs & Quality Assurance Specialist at dicentra, has ten years of experience working in the field of pharmaceutical and natural health products quality assurance and often delivers lectures on GMP issues with Health Canada. William assists dicentra’s U.S. based clients in establishing the necessary requirements to import their products under a Health Canada issued Site License.



Classification of Products at the Cosmetic-Drug Interface: a Deeper Look
Wednesday, May 26, 2010, 1:00 PM Eastern Time
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60 minutes followed by a 30 minute question and answer period
William Morkel & Clara Di Tella
1 Certificate of Course Completion issued to the attendee, and archive of the PowerPoint and audio to keep forever

Many products fall under the cosmetic-drug interface. These are products that may share the characteristics of both a cosmetic and drug, as defined in the Food and Drugs Act, making them more difficult to classify. Such products may include acne therapy, anti-perspirants, sunburn protectants, tooth whiteners, and many others. In Canada, these products can be regulated by the Cosmetic Regulations, Food and Drug Regulations, or the Natural Health Products Regulations, depending on their ingredients and the claims they make. This webinar was created to help clarify how products of this nature are classified, to capitalize on allowable health claims, and to save time and money by avoiding unnecessary regulatory burdens as a result of misclassification. Topics covered include:

• procedures on how to accurately classify your product as a cosmetic, natural health product, or drug
  
• an overview of the regulatory requirements for each category and how they differ;
  
• instructions on how to mitigate risk and ensure regulatory compliance;
  
• strategies to capitalize on allowable, unique and strong claims; and,
  
• a list of product categories that have recently experienced a category transition.

This seminar is being presented by William Morkel and Clara Di Tella.

William Morkel, Senior Regulatory Affairs & Quality Assurance Specialist at dicentra, has ten years of experience working in the field of pharmaceutical and natural health products quality assurance and regulatory affairs. Clara Di Tella is dicentra’s primary advisor for regulatory affairs and labeling requirements for cosmetics.



Good Manufacturing Practices Training for Natural Health Product Site License Holders
Wednesday, July 28, 2010, 1:00 PM Eastern Time
Add a reminder to your calendar
120 minutes followed by a 30 minute question and answer period
William Morkel
Certificates of Course Completion issued for up to 5 attendees and 1 corporate certificate for GMP training
Archive of the PowerPoint and audio to keep forever

All facilities involved in the manufacturing, importing, packaging or labeling of natural health products in Canada should now have a Site License from the Natural Health Products Directorate (NHPD). This requirement has been in place now for over two years and in the interim, policies and procedures have changed as the NHPD has raised its expectations in terms of the documentation required to support an application. At the heart of a successful license application or renewal is compliance with the Good Manufacturing Practices (GMPs). Manufacturers, packagers, importers, and labelers must implement a GMP compliant quality system and must ensure that individuals on staff receive initial and ongoing GMP training. This course, prepared and delivered by William Morkel, will provide participants with the information and tools necessary to facilitate compliance with the regulations and will address issues and concerns with the interpretation and implementation of the GMP requirements.

This course is specifically designed for potential and current Site License holders. Any personnel directly involved in the manufacturing, importing, packaging or labeling of natural health products should attend this course in order to ensure that they have adequate training to control and supervise these activities under GMP requirements.

William Morkel, Senior Regulatory Affairs & Quality Assurance Specialist at dicentra, has ten years of experience working in the field of pharmaceutical and natural health products quality assurance and often delivers lectures on GMP issues with Health Canada. This seminar has been presented by William to many of Canada’s largest companies in the natural health product industry as part of their annual GMP training.