The Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs) is a prestigious advanced qualification designed for professionals seeking to elevate their expertise in the rapidly evolving field of pharmaceutical regulation. This programme is not intended for fresh entrants but is specifically tailored for experienced professionals aiming to enhance their career prospects, broaden their knowledge base, and actively contribute to their Continuing Professional Development (CPD).
This postgraduate diploma equips learners with a comprehensive understanding of regulatory frameworks governing the pharmaceutical industry, including national and international standards, compliance strategies, and quality assurance processes. Learners will gain the skills necessary to interpret complex regulations, implement best practices in regulatory submissions, and ensure that pharmaceutical products meet the highest safety, efficacy, and quality standards.
Delivered in alignment with international standards, the programme emphasises practical application alongside theoretical knowledge. Learners will engage in critical analysis, research projects, and real-world case studies, enabling them to make informed decisions that positively impact organisational performance and regulatory compliance.
Centres offering this qualification are required to maintain the highest standards of delivery. They must employ competent and qualified staff with expertise in pharmaceutical regulatory affairs and provide access to all necessary materials, resources, and facilities. This ensures a rich, high-quality learning experience that supports learner success and professional growth.
By completing this Level 7 Postgraduate Diploma, learners position themselves as leaders in pharmaceutical regulatory affairs, ready to navigate complex regulatory environments, influence strategic decision-making, and drive excellence within their organisations.
Course Overview
Qualification Title
LICQual Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs)
Total Units
6
Total Credits
120
GLH
600
Qualification #
LICQ2201226
Qualification Specification
To enroll in the Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs (PgD Regulatory Affairs) , applicants must meet the following criteria:
|
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 |
By the end of this course, learners will be able to:
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.
This programme is designed for experienced professionals aiming to advance their careers in pharmaceutical regulatory affairs. It is ideal for:
- Regulatory affairs professionals seeking to enhance their expertise in compliance, dossier preparation, and regulatory submissions.
- Pharmacists and life sciences graduates aiming to transition into leadership roles within regulatory or quality assurance departments.
- Healthcare and pharmaceutical managers looking to develop advanced knowledge of regulatory frameworks, clinical trial compliance, and pharmacovigilance.
- Quality assurance and safety officers who wish to deepen their understanding of risk management and regulatory compliance.
- Professionals pursuing strategic or leadership positions in pharmaceutical companies, regulatory agencies, or healthcare organisations.
- Individuals committed to Continuing Professional Development (CPD) and evidence-based practice in pharmaceutical regulatory affairs.
- International professionals seeking a globally recognised Level 7 qualification aligned with international regulatory standards.
This course equips learners with the knowledge, skills, and practical expertise required to lead regulatory teams, navigate complex compliance landscapes, and contribute strategically to organisational success.
To deliver the Level 7 Postgraduate Diploma in Pharmaceutical Regulatory Affairs effectively, centres must meet the following requirements:
- Accreditation and Recognition: Centres must be accredited by recognised national or international educational authorities and approved to deliver postgraduate-level programmes in pharmaceutical or healthcare-related fields.
- Qualified Academic Staff: Centres should employ competent and experienced teaching staff with expertise in pharmaceutical regulatory affairs, quality assurance, and healthcare leadership at Level 7 or equivalent.
- Learning Resources: Centres must provide access to comprehensive learning materials, including textbooks, regulatory guidelines, research journals, case studies, and digital learning platforms.
- ICT and Online Learning Infrastructure: Reliable internet access, computers or laptops, and secure online platforms are required to facilitate interactive learning, research, and assessment activities.
- Practical and Research Facilities: Availability of facilities for project work, simulations, and research activities relevant to pharmaceutical regulatory affairs is essential.
- Assessment and Quality Assurance Systems: Centres should maintain robust assessment processes, including formative and summative evaluations, and implement quality assurance measures aligned with international standards.
- Learner Support Services: Centres must provide academic guidance, career advice, and access to professional networks to support learners’ progression and success.
These requirements ensure that centres deliver a high-quality, internationally recognised programme, equipping learners with the skills, knowledge, and practical experience needed to excel in pharmaceutical regulatory affairs and leadership roles.
Assessment and Verification
All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.
To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.
Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.
