Everything You Need to Know About Health Canada's Cannabis Packaging Requirements!

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Live Webinar: Health Canada’s Packaging and Labelling Requirements for Cannabis Products Greetings! This webinar examines Health Canada’s Packaging and Labelling requirements for different cannabis classes as well as different product forms. Gain practical understanding of the packaging and labelling requirements as well as how to avoid common mistakes and misinterpretations.   Who Should Attend? This course is designed for: Any individual with interest in Cannabis Regulatory Affairs, Quality Assurance, Product Development and Operations LEARN MORE Course Outline Cannabis classes and different product forms Health Canada Packaging requirements Health Canada labelling requirements Special considerations Packaging and Labelling examples: HC and Industry examples Common mistakes Packaging and labelling requirements for license amendments Q&A     LEARN MORE Date and Time: December 13, 2022 2:00 PM - 3:00 PM (EST) How is the webinar delivered? Live, interactive, instructor-led GET CERTIFIED TODAY! Interested in this workshop? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca. Academy of Applied Pharmaceutical Sciences

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New Medical Device Regulations! What do you need to know?

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Medical Devices Regulation in Canada – Principles and Recent Updates Workshop December 9, 2022 | 9:00AM - 5:00PM Medical devices companies who develop their products and wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices. Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products. LEARN MORE Course Outline Introduction Canadian regulations of medical devices Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU) Mutual recognition of data between various regulatory authorities Preparation and submission of Pre-ITA, ITA, Licensing application Quality systems according to ISO 13485:2016 GMP Risk management according to ISO 14791 Clinical trials Vigilance program Preparation for audits in compliance with Health Canada requirements New Canadian regulatory requirements REGISTER TODAY Academy of Applied Pharmaceutical Sciences

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Drug submission preparation in CTD and eCTD formats

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Drug Product Submission (NDS) Preparation in CTD and eCTD format Workshop December 06, 2022 Greetings! This course will give participants the necessary overview of the Health Canada guidance documents for the preparation of a new Drug Submission (NDS) for Chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed and participants will work on a mock submission binder. Course Outline Drug Development and NDS preparation Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format CTD Structure and Content Structure of Drug Regulatory Activities in the Common Technical Document (CTD) Format Module 1: Administrative and Product Information Module 2: Common Technical Document (CTD) Summaries Module 3: Quality Module 4: Nonclinical Study Reports Module 5: Clinical Study Reports Get Certified! LEARN MORE ABOUT THE WEBINAR IN DETAIL Contact Us to Get Registered Today! Call Chat Schedule Follow us on Social to get regular news and updates!

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Hi , how to classify and report ADEs? Find out today!

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Drug Safety and Adverse Drug Reaction Reporting Workshop December 02, 2022 Register Now! Workshop Details Time - 9:00 am - 5:00 pm Cost - CAD $645 + HST Location - Online. Live. Interactive. Instructor Led Abstract: This workshop will explain the importance of adverse drug reactions, the Canadian MedEffect Scheme, the source of adverse drug reaction reports and the differences between serious and non-serious events. In addition, a MedEffect form will be completed in class. Course Outline On completion of this workshop students should be able to: explain the importance of adverse drug reaction reporting explain the importance of the Canadian MedEffect system understand the source of safety reports explain how the safety reporting Scheme works differentiate between serious and non-serious ADRs and identify when completion and submission of MedEffect forms is required complete a MedEffect form   Certificate of Attendance and Course Material All participants will receive a certificate of attendance upon completion of the course. The participants will be receiving specially prepared course manual. Get Certified! LEARN MORE ABOUT THE WORKSHOP IN DETAIL Follow us on Social Media to get regular news and updates!

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