Filing a Successful Cannabis Application
Expired

  • September 19, 2018
    9:30 am - 5:00 pm

Location

15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4
M M QA RA

Certification Areas

Health Canada’s new updated Cannabis Act will become effective this Fall.  Learn about the upcoming regulations and get up to date with Good Production Practices (GPP) so that you are ready for October 17, 2018.

 

Course Outline:

  • Review of Cannabis act and its regulations coming into force October 17, 2018 and differences to current regulations
  • Requirements to transition a licence or application to the new Health Canada CTLS system
  • Cannabis Licence Options
  • Parts of a Cannabis Licence Application (phys. security, site information, quality assurance report, record keeping etc.)
  • Filing a Cannabis Licence Application with Health Canada
  • What to expect during application review by Health Canada
  • Confirmation of readiness letter & Health Canada audit
  • More Details on Quality Assurance and Good Production Practice (GPP) for cannabis

 

Who should attend:

  • Staff from the Cannabis Industry
  • Individuals interested in obtaining a licence to produce, process, test and sell cannabis
  • Quality Assurance Associates and Managers
  • Regulatory Affairs Associates and Managers
  • Individuals who would like to perform R & D with cannabis

 

Speaker Bio:

  • Mrs. Elfi Daniel-Ivad serves as Head of Submissions at Eurofins Experchem Laboratories Inc. In this role, she leads a team of regulatory professionals in the development of regulatory submission strategies for Natural Health Products (NHPs), OTC drugs, cosmetics, medical devices, food products, site licenses and medical establishment licences. In addition, Mrs. Daniel-Ivad manages post-approval changes to ensure regulatory compliance and spearheads pharmacovigilence activities in close collaboration with clients and medical professionals including the preparation of periodic safety update reports (PSURs). Over the last decade, Mrs. Daniel-Ivad has developed a proven style of dealing with Health Canada authorities resulting in an excellent track record of getting regulatory submissions and applications approved. Her responsibilities include also the regulatory review of NHP, OTC drugs, cosmetics, food, household chemical and medical device labels ensuring compliance with Canadian regulations. Mrs. Daniel-Ivad also has experience in preparing protocols and reports for method validations, equipment qualification, transportation, and temperature cycling studies. In addition, in the last four years Mrs. Elfi Daniel-Ivad worked with countless medical marihuana producer licence applicants to receive growing and sales licence from Health Canada. Mrs. Daniel-Ivad received a B.Sc. in Technical Chemistry and a M.Sc. in Biotechnology and Nutrition from the Technical University of Graz, Austria. Further, she received a Postgraduate Regulatory Affairs Diploma (PRA) from the Academy of Applied Pharmaceutical Sciences Inc. (AAPS), Toronto.

 



Student Ticket: $250.00 Sold Out
Basic Non-Member Ticket: $650.00 Sold Out
Group Tickets (5+): $550.00 Sold Out
Pro/Pro Plus Member Ticket: $575.00 Sold Out