New Webinar from dicentra – Marihuana for Medical Purposes Regulations (MMPR)

June 26, 2014 By

MARIHUANA FOR MEDICAL PURPOSES REGULATIONS (MMPR) WEBINAR

Understanding the Marihuana for Medical Purposes Regulations (MMPR), Overcoming the Hurdles in Becoming a Licensed Producer of Medical Marihuana, and Understanding Potential Costs and Market Size.

Hundreds of companies and investors are rushing to become a licensed producer but becoming one under the new MMPR can be a real challenge. It requires a clear understanding of MMPR, the Directive on Physical Security Requirements for Controlled Substances, and the steps required in establishing a production facility and complying with Health Canada expectations.

We have a long term working relationship with the Health Canada Office of Controlled Substances as well as expertise in the areas of MMPR, Good Production Practices, Quality Assurance, Standard Operating Procedures, and in establishing a compliant production facility. For this reason we provide you with this in-depth webinar to provide clarity on all the steps required in becoming a licensed producer under the new regulations, also covering all of the issues to consider in remaining a licensed producer, and finally a close look at expected costs and total market size.

Training Options

Attend Live Online Training Only

September 24, 1:00 PM EST
$349 CAD + applicable tax
One dial-in
Click to Register

Access Recorded Version

Unlimited access for 3 months
$449 CAD + applicable tax
Click to Register

This comprehensive webinar focuses on the current Health Canada Marihuana for Medical Purposes Regulations, outlining the challenges and solutions in becoming a licensed producer of Medical Marihuana under the new regulations as well as the procedures in establishing a production facility compliant with Good Production Practices, Health Canada MMPR and the Directive on Physical Security. Projected Costs and potential market size are also covered. For full details please see below.

AREAS COVERED IN THE WEBINAR

  • Overview of the Health Canada Marihuana for Medical Purposes Regulations
  • Overview of the Directive on Physical Security Requirements for Controlled Substances
  • Steps in establishing a working relationship with the Health Canada Office of Controlled Substances
  • Ongoing communication with the Health Canada Office of Controlled Substances
  • Health Canada audit and licensing process
  • Steps in completing the application to become a licensed producer under the new MMPR regulations
  • Steps in establishing a production facility
  • Overview of required Standard Operating Procedures
  • Development and implementation of Good Production Practices (GPP) and a compliant quality system
  • Definition of and requirements for mandatory on site staff, including Quality Assurance person
  • Importation and Exportation of Medical Marihuana and pertinent permits
  • Insurance for the production facility and for the stored and transported Medical Marihuana
  • Distribution methods of Medical Marihuana to clinics, physicians and hospitals
  • Overview of Medical Marihuana strains for specific aliments listed by Health Canada and ailments accepted by Health Canada for Medical Marihuana use
  • Current legal status of MMPR with the federal courts
  • Projected upfront and ongoing cost of compliance
  • Projected patient population and market size

WHO WILL BENEFIT

  • Potential and current MMPR licensed producers
  • Senior, Responsible, Alternate Responsible and Quality Assurance personnel in a licensed facility
  • Physicians, naturopathic doctors, hospital and clinic personnel
  • Municipality, police and fire department personnel
  • Health Canada and government employees
  • Lawyers and consultants
  • Investors

PROFILES OF INSTRUCTORS

KarolDr. Karol Wojewnik, M.D.

Dr. Karol Wojewnik M.D. is a recognized health expert who is highly knowledgeable in Marihuana for Medical Purposes Regulations, the classification of cannabinoids and Medical Marihuana, and in Health Canada expectations pertaining to becoming a certified licensed producer under the new MMPR. He is an active member of several Canadian and international cannabis associations.

Dr. Karol is also an expert in conventional medicine, supplementation, botanical medicine, clinical nutrition and diet and exercise programs.

In his current role as the Medical Director and senior advisor for dicentra, Dr. Karol reviews scientific reports and compiles reports for Health Canada and the U.S Food and Drug Administration to help companies bring new products and ingredients to market. He also manages all client accounts related to MMPR.

Dr. Karol holds a Bachelor of Science and a Medical Doctor degree with distinction.

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RW_William_2701William Morkel

William has 15 years of Regulatory Affairs and Quality Assurance experience pertaining to the regulation of health-care and health-related products in the United States and Canada.William has both practical and technical knowledge of the industry, having worked in manufacturing, packaging, labelling, and laboratory testing settings prior to his role as a senior level consultant. He is a regular contributor to trade and industry publications and served on the Working Group to the Health Canada Program Advisory Committee for Product Testing Requirements Connected to Good Manufacturing Practice (GMP) Requirements.In his current role as Director of Quality & Compliance at Dicentra, William oversees internal operations to ensure clients receive proper and reliable regulatory guidance in the context of their business models, and provides stakeholders with strategic solutions towards achieving compliance with regulatory requirements. His activities include Product Classifications, Establishing Quality Control Standards, Developing/Implementing Quality Systems, Auditing, Site and Establishment Licencing, Overseeing Importation Activities, Regulatory and GMP Training, Reviewing Promotional/Advertising

Materials, and Responding to Access to Information Requests.

William holds an Honours Bachelor of Science in Biology and Physics and completed the Pharmaceutical Regulatory Affairs and Quality Assurance Certificate Program with honours.