LICQual Level 7 PgD in Pharmaceutical Regulatory Affairs
In today’s global healthcare environment, the safety, quality, and compliance of medicines are non‑negotiable. Every drug, vaccine, and medical product must meet strict international standards before reaching patients, and this is where pharmaceutical regulatory affairs play a critical role. This discipline ensures that pharmaceutical innovations are not only effective but also legally compliant, ethically sound, and aligned with global frameworks.
The LICQual Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs) highlights the growing importance of professionals who can navigate complex regulations, manage approvals, and safeguard patient safety. Pharmaceutical regulatory affairs are not just about paperwork—they are about protecting lives, ensuring transparency, and building trust between healthcare providers, governments, and patients. As the demand for new therapies rises worldwide, experts in this field are essential for bridging scientific discovery with regulatory compliance. For learners, engaging with pharmaceutical regulatory affairs is more than academic—it is an opportunity to influence healthcare systems, strengthen professional credibility, and play a pivotal role in advancing safe and effective medicine.
Program Outline
The LICQual Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs) is a structured qualification designed to provide learners with advanced expertise in compliance and regulatory management. Comprising 6 specialized units and worth 120 credits, the program introduces learners to areas such as international regulatory frameworks, drug approval processes, patient safety standards, compliance audits, ethical considerations, and global best practices in pharmaceutical regulatory affairs.
This section explains how the course equips learners with the ability to understand pharmaceutical regulatory affairs, apply evidence‑based approaches, and align with international standards effectively. It highlights the type of learners the program is aimed at, the skills they will gain, and the career pathways available upon completion. Readers will also discover how this internationally recognized qualification opens opportunities in hospitals, pharmaceutical companies, healthcare organizations, and research institutions, making it a valuable credential for anyone aspiring to build a career in pharmaceutical regulatory affairs.
Unit Structure
| Qualification | Unit Title | Credits | GLH |
| LICQ2201226-1 | Regulatory Frameworks in Pharmaceuticals | 20 | 100 |
| LICQ2201226-2 | Clinical Trials and Regulatory Compliance | 20 | 100 |
| LICQ2201226-3 | Quality Assurance and Risk Management | 20 | 100 |
| LICQ2201226-4 | Regulatory Submission and Documentation | 20 | 100 |
| LICQ2201226-5 | Advanced Pharmacovigilance and Safety Reporting | 20 | 100 |
| LICQ2201226-6 | Regulatory Affairs Leadership Project | 20 | 100 |
Who Can Benefit
The LICQual Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs) is designed for individuals who want to specialize in compliance, regulation, and governance within pharmaceutical practice. This program is particularly valuable for those who aim to address challenges such as drug approval, patient safety, and adherence to international standards. It helps learners strengthen their expertise, improve employability, and prepare for roles where pharmaceutical regulatory affairs are central to healthcare delivery.
Ideal Learners
- Students aspiring to enter pharmaceutical sciences with a focus on compliance.
- Entry‑level professionals seeking structured training in pharmaceutical regulatory affairs.
- Pharmacy assistants wanting to expand knowledge of drug approval and patient safety.
- Community pharmacy staff preparing for responsibilities in healthcare compliance.
- Hospital pharmacy technicians aiming to strengthen skills in audits and regulatory frameworks.
- Healthcare professionals transitioning into pharmaceutical regulatory affairs roles.
- Career changers interested in healthcare governance and pharmaceutical innovation.
- Ambitious learners who want to develop practical skills for pharmaceutical regulatory affairs careers.
What You’ll Be Able to Do
Unit 1: Regulatory Frameworks in Pharmaceuticals
learners will be able to:
- Critically evaluate national and international regulatory frameworks governing pharmaceutical products.
- Analyse the impact of legislation and regulatory policies on drug development, approval, and distribution.
- Apply regulatory knowledge to ensure compliance and mitigate legal and operational risks.
- Develop strategic approaches to align organisational practices with regulatory requirements.
Unit 2: Clinical Trials and Regulatory Compliance
learners will be able to:
- Critically assess regulatory requirements for the design, conduct, and monitoring of clinical trials.
- Evaluate ethical considerations and Good Clinical Practice (GCP) guidelines in clinical research.
- Apply compliance strategies to manage trial documentation, safety reporting, and regulatory submissions.
- Analyse challenges in clinical research and propose solutions to ensure regulatory adherence.
Unit 3: Quality Assurance and Risk Management
learners will be able to:
- Critically evaluate quality management systems within pharmaceutical operations.
- Identify and assess risks across manufacturing, distribution, and regulatory compliance processes.
- Develop and implement effective risk mitigation and quality assurance strategies.
- Apply evidence-based approaches to enhance product safety, efficacy, and regulatory compliance.
Unit 4: Regulatory Submission and Documentation
learners will be able to:
- Analyse regulatory submission requirements and dossier structures, including the Common Technical Document (CTD).
- Develop accurate, high-quality regulatory documentation for submission to approval authorities.
- Critically evaluate submission strategies to ensure timely regulatory approvals.
- Apply project management principles to oversee the preparation and review of regulatory submissions.
Unit 5: Advanced Pharmacovigilance and Safety Reporting
learners will be able to:
- Critically assess pharmacovigilance requirements and international safety reporting standards.
- Monitor and evaluate adverse drug reactions, signal detection, and risk communication.
- Develop strategies for proactive pharmacovigilance and regulatory compliance.
- Apply analytical skills to improve patient safety and organisational regulatory practices.
Unit 6: Regulatory Affairs Leadership Project
learners will be able to:
- Design and implement a regulatory affairs project addressing a practical challenge in the pharmaceutical sector.
- Demonstrate advanced problem-solving, leadership, and project management skills.
- Critically evaluate project outcomes using appropriate performance indicators.
- Reflect on regulatory leadership practice and propose evidence-based recommendations for organisational improvement.
