Professional Regulatory Affairs

Live Session

Certificate Awarded: Professional Regulatory Affairs – Certificate
Level of Training: Beginner | Intermediate
Mode of Delivery: Online / Onsite / Recorded Program
Fee: $960

Both Online and OnCampus training is available

Take an Appointment with Program Advisor

Program 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 program 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 wish to become Regulatory Affairs pharma Associate, QA Associates, or related roles may attend this program.

Attendees may interact with the class and lead trainers for more clarifications or concerns.

Program Offers

Register for 3 certificate programs at NACPT and get any available 1-day training for free.
Attendees will be issued the certificate of completion at the end of training program.

Additional Program Info

Program Module
Learning Outcomes
Job Opportunities
Who Should Attend

Program Module

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

Learning Outcomes

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

Job Opportunities

Regulatory Affairs Associates
Regulatory Affairs Coordinators
Auditors and Inspectors

Who Should Attend

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

Faculty of Professional Regulatory Affairs

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.

More Detail