Regulatory Affairs Training

Master Pharmaceutical Compliance and Market Authorization

Regulatory affairs forms the critical link between pharmaceutical companies and health authorities, ensuring vital products reach the market safely. Jeyflex offers superior regulatory affairs training by bridging the gap between theory and practice. Led by active consultants managing real submissions, our curriculum empowers you to navigate complex African regulations, master dossier compilation, and secure market approvals with unmatched professional confidence.

Professional training in regulatory affairs and pharmacovigilance course overview

MODULE 1: Regulatory Affairs Training

This extensive regulatory affairs course provides a deep dive into the legal and technical frameworks governing the pharmaceutical industry in Africa. Designed to transform trainees into competent specialists capable of managing the full product lifecycle—from initial registration to post-market maintenance—the curriculum focuses on building practical expertise in the following core areas:

Product Registration & Classification

Master the registration requirements for a wide range of health technologies, including Human and Veterinary Pharmaceuticals, Medical Devices, In-Vitro Diagnostics (IVDs), Herbal Medicines, and Borderline Products.

Dossier Compilation & Submission

Learn the technical standards for compiling, auditing, and submitting eCTD dossiers to regulatory authorities, including the PPB, TMDA, and EFDA, for successful regulatory submissions.

Lifecycle Management

Navigate critical post-registration processes, including handling variations, license renewals, and ensuring compliance in marketing and product promotion.

Professional Soft Skills

Beyond technical skills, we train you in emotional intelligence and customer experience management—essential traits for successful regulatory consultants.

Course Duration: 80 Hours (Flexible scheduling based on client availability)

Module 2: Specialized Pharmacovigilance Training

Safety monitoring is a non-negotiable aspect of the healthcare landscape. Our dedicated pharmacovigilance course equips professionals with the critical skills to detect, assess, and prevent adverse effects in compliance with international standards. This module is structured to provide a thorough grounding in drug safety, guiding trainees through the following essential competencies:

Pharmacovigilance Systems

Explore quality management, audits, and the Pharmacovigilance System Master File (PSMF).

Risk Management & Reporting

Develop Risk Management Plans(RMPs)and master adverse reaction reporting, including vaccine and medical device vigilance.

Signal Detection & Safety Communication

Learn to identify safety signals and communicate effectively with stakeholders.

Entrepreneurial Insights

Discover how pharmacovigilance drives organizational success and explore future trends like AI in drug safety.

60 Hours (Flexible scheduling based on client availability)

Why Choose Jeyflex for Regulatory & PV Training?

Our Training Advantage

  • Active Practitioner-Led Learning: Gain insights from experts currently working with the PPB, TMDA, EFDA, and other African National Regulatory Authorities (NRAs).

  • Pan-African Regulatory Expertise: Our curriculum is specifically tailored to the unique regulatory landscapes of East, West, and Southern Africa, ensuring your skills are relevant where they matter most.

  • Practical, Job-Ready Skills: We move beyond theory. You will work on practical exercises like eCTD dossier compilation, RMP development, and mock safety reporting to ensure you are job-ready from day one.

  • ISO 9001:2015 Certified Quality: Train with a partner that adheres to global quality standards. Our ISO certification guarantees that our training processes are rigorous, consistent, and internationally recognized.

  • Flexible Delivery Models: Whether you need in-house corporate workshops or virtual pharmacovigilance short courses, we adapt our delivery to fit your team’s schedule and learning style.

FAQs About Jeyflex Training Programs

Yes. We understand that these fields are closely linked. You can choose to specialize in just one area or enroll in our integrated regulatory affairs and pharmacovigilance courses to gain a dual skillset. This combined approach is highly recommended for professionals seeking a comprehensive understanding of the pharmaceutical product lifecycle.

Absolutely. Our pharmacovigilance short courses are structured to accommodate both beginners and experienced professionals. Whether you are a recent graduate looking for a course in regulatory affairs pharmaceutical industry entry or a working professional needing a refresher, our modules are adjustable to your current experience level.

We offer flexible learning models to suit your needs. Jeyflex provides both in-person workshops at our training facilities and virtual sessions for remote learners. This flexibility ensures you can access top-tier regulatory affairs training from anywhere in Africa.

Yes. Upon successful completion of the regulatory affairs course or the PV module, trainees receive a Certificate of Completion from Jeyflex Consultants. This certificate validates your practical skills and is widely respected by employers in the region.

While a background in life sciences (Pharmacy, Chemistry, Biology, or Medicine) is beneficial, it is not always mandatory. If you are looking to pivot your career, our regulatory affairs course provides the foundational knowledge needed to start a career in compliance.

The duration depends on the specific module. Typically, the comprehensive regulatory affairs training runs for 80 hours, while the specialized pharmacovigilance course runs for 60 hours. We can also customize the timeline for corporate groups.

Interested In Our Training Services?

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Pharmaceutical Compliance Solutions for Algeria