Professional Regulatory Affairs

 

CERTIFICATE TRAINING


Live Session

Certificate Awarded: Professional Regulatory Affairs - Certificate

Time: 9.30 AM – 4.30 PM

Level of Training: Beginners | Intermediate

Mode of Delivery: Live Interactive Instructor-led Webinar

Date: September 9th, 2021

Fee: $960

(Contact us for the Recorded webinar)

Professional Regulatory Affairs

Regulatory affairs

Webinar Overview

  • Regulatory approval and communication processes involving cannabis, pharmaceutical and biotechnology drugs as well as NHPs and medical devices are key factors in the cannabis industry. Hence, candidates with in-depth Professional Regulatory Pharma Affairs knowledge are in high demand.
  • This regulatory affairs training webinar on Professional Regulatory Affairs focuses on health care legislation, international health care system, process, procedures, and practices for regulating the product development, manufacturing processes, quality assurance and marketing of various health care products.
  • Aspirants who want to become Regulatory Affairs pharma Associate, QA Associates, Quality Assurance Person (QAP), Regulatory Professionals should attend this webinar on regulatory affairs training.

 

Course Offers

  • Register for 3 webinars at NACPT and get any available 1 – day certificate training for free.

Please note that the certificate of completion will be issued at the end of training.

  1. Module 1
  • International, Health Canada, and FDA’s laws, regulations, and Guidelines
  • Investigational and marketing applications
  1. Module 2
  • Technical writing, negotiation skills
  • Development of New Drug Application (NDA) submissions
  • Labeling and drug Information
  1. Module 3
  • Electronic Common Technical Documents (eCTD)
  • Notice of Compliance (NOC)
  1. Module 4
  • Good Clinical Practices (GCPs)
  • Requirements for ongoing post-marketing surveillance
  • Post-marketing changes, communication and management skills
  • Case study
  1. Module 5
  • Good Clinical Practices (GCPs)
  • Requirements for ongoing post-marketing surveillance
  • Post-marketing changes, communication and management skills
  • Case study
  1. Module 6
  • Regulatory Affairs for the cannabis industry
  • Cannabis regulations act
  • Post-marketing changes, communication and management skills

After successful completion of this course, students will be :

  • Able to understand the current regulatory affairs framework
  • Able to prepare for NDA
  • Able to submit NDA
  • Able to perform other regulatory affairs activities
  • Regulatory Affairs Associates
  • Regulatory Affairs Coordinators
  • Auditors and Inspectors

Anyone who wants to become the following should attend this webinar on regulatory affairs training

  • Regulatory Affairs Associate
  • QA Associates
  • Quality Assurance Person (QAP)
  • Regulatory Professionals

 

Muaz Ahmed

B.Sc., Toxicology, Post-Graduate in Clinical Research

 

Muaz Ahmed has over 7 years of clinical research experience and currently working in Scimega Research Inc as a Clinical Research Associate. He was the Team Lead and Clinical Research Coordinator at the Department of Surgical Oncology (Genitourinary) Clinical Trials and Genitourinary BioBanking Team, Princess Margaret Cancer Centre, University Health Network from 2012 to 2015. Mr. Ahmed also worked as a Clinical Research Coordinator from 2009 to 2013 in the Primary Care Lung Clinic. A B.Sc. graduate in Toxicology from the University of Toronto Mr. Ahmed completed Post Graduation in Clinical Research from Humber College, Toronto before starting his career in clinical research. His extensive knowledge and experience dealing with clinical trial regulation, standards, protocol development and monitoring make him a unique professional in the field of Clinical Research.

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+1 416 412 7374  +1 647 998 7374

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