Regulatory Affairs
Master the skills needed to navigate the complex regulatory landscape, stay ahead in the industry, and boost your professional growth.
Executive Summary
Regulatory Affairs professionals play a critical role in ensuring research and development processes for health products and technologies are done in compliance with regulatory requirements. They are also involved in the registration of health products and technologies before they can be introduced into any country for use by patients. In this process, regulatory affairs professionals require skills and competencies to:
- Source for regulatory frameworks and guidelines applicable to the regulatory function in question.
- Comprehend regulatory requirements
- Analyse, synthesize and disseminate regulatory requirements to various teams in the research and development team during product development.
- Compile, review and submit regulatory documents for regulatory review by regulatory agencies.
- Coordinate responses to regulatory queries to ensure timely registration of medicines.
- Lead strategic policy work in the industry to inform regulatory frameworks and policies impacting the industry.
Regulatory Affairs professionals work in industry, with development partners, regulatory agencies among others with these skills and competencies needed across the different sub-sectors.
This course is designed to learners with basic skills and competencies required for a fulfilling career in Regulatory Affairs.
Course Objectives
- To promote understanding of basic principles of regulatory affairs in the biopharmaceutical industry spanning pharmaceuticals, medical devices, clinical trials, policy and research & development.
- To equip learners with skills to execute regulatory affairs functions ranging from dossier preparation, submission and regulatory agency engagements.
- To integrate regulatory compliance, regulatory intelligence and quality assurance in regulatory affairs activities.
- To expose graduates to career opportunities in regulatory affairs.
Course Structure
Core Lectures
Guest Lectures
Case Presentations
Mode of Delivery & Duration
The program will be delivered virtually on Microsoft Teams.
The course runs for 12 weeks. Each session will run for 2hrs weekly.
Modules
- Introduction to Regulatory Affairs – basic overview of regulatory affairs principles and concepts including international protocols, frameworks & standards.
- Business Fundamentals of Regulatory Affairs – understanding the business use case of regulatory affairs knowledge and concepts in biopharmaceutical operations.
- Regulatory Affairs in Biopharmaceuticals & Pharmaceutical Products – understanding the regulatory considerations for dossier compilation, submission assessment and life cycle management for biopharmaceuticals.
- Regulatory Affairs for Clinical Trial Management – focusing on the regulatory requirements and processes in clinical trial application, management and reporting.
- Regulatory Affairs in Medical Devices and In-Vitro Diagnostics – understanding of the regulatory principles and processes in handling regulatory functions for medical devices.
- Regulatory Affairs for Borderline Products including Cosmetics, Herbal Products, Nutraceuticals – understanding the principles and processes in the regulation of borderline products and complementary medicine.
- Quality Assurance and Compliance in Regulatory Affairs – understanding the QA & compliance principles in regulatory functions.
- Fundamentals of Regulatory Policy and Intelligence – understanding regulatory policies, regulatory systems strengthening approaches and business case for the same.
- Emerging Trends in Regulatory Affairs in Africa – a spotlight on emerging developments, opportunities, policy priorities and environment shaping interventions in the continent for regulatory affairs.
- Career Opportunities in Regulatory Affairs – scoping of practice environments for RA professionals.
Target Participants
Professionals with at least an undergraduate training in biological and pharmaceutical sciences with interest in Regulatory Affairs.
Why Should You Enroll?
- Get the the skills and competencies to venture into a lucrative career in Regulatory Affairs.
- Gain global exposure and networks in Regulatory Affairs.
- Be on the front seat to shape Africa’s regulatory landscape towards a thriving industry on the backdrop of African Medicines Agency (AMA) establishment.
- Gain skills to translate regulatory knowledge and work into business value for decision making in corporate strategies.
Dr. Anushree Patel
Regulatory Affairs Pharmacist
Regulatory Affairs Pharmacist with experience in drug registration, life cycle management, audit and compliance to GxP functions. She has practiced both in the pharmaceutical industry and currently works with a national medicines regulatory agency (NMRA) involved in regulatory functions ranging from product assessment, quality audits and institutional development plans formulation towards regulatory systems strengthening.
Dr. Odhiambo David
Policy Analyst
Regulatory Affairs Manager with innovative biopharmaceutical company with responsibilities in regulatory process improvements, compliance, team development, regulatory execution and performance management. He is the Curator, African Pharmaceutical Network and a Board Member, Kenya Association of Pharmaceutical Industry.
Dr. Teresa Nyongesa
Regulatory Affairs Specialist
Pharmacist with six years of experience in regulatory affairs. She has dedicated her career to the critical task of ensuring that medicines meet regulatory standards. She is passionate about making tangible difference in patients’ lives by ensuring that they have access to quality, safe, and effective medicines. Her background in Pharmacy has set the pace for her career and she is currently broadening her horizons by pursuing a master’s in health economics and policy at the University of Nairobi.
Dr. Denish Kineni
Regulatory Affairs Specialist
Regulatory Affairs Specialist with experience in biopharmaceuticals, clinical trials and regulatory compliance operations. He has a master's in health economics from the University of Nairobi and is committed to optimizing access to innovative healthcare solutions in Africa through efficiencies in regulatory operations.
Regulatory Affairs Alumni
"The training enhanced my regulatory affairs skills, was informative, and eye-opening, especially on regulatory systems in Africa. I've gained valuable insights and look forward to advancing my career."
"APN's Regulatory Affairs Training transformed my limited understanding into in-depth knowledge, offering practical insights, expert mentorship, and invaluable industry connections—truly a worthwhile investment for anyone pursuing a career in regulatory affairs."
"APN's Regulatory Affairs Training offers unmatched industry insights from experienced facilitators and guest speakers, revealing the vast scope of regulatory affairs and its impact on the pharmaceutical and health sectors—highly recommended for anyone exploring this field!"
"The APN Regulatory Affairs Short Course is a highly practical and relevant program, led by industry professionals, that bridges curriculum gaps and provides invaluable skills and networking opportunities for anyone pursuing a career in regulatory affairs."
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