The LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs (Dip Regulatory Affairs) is a specialised qualification designed to equip learners with advanced knowledge and skills in navigating the complex regulatory landscape of the pharmaceutical industry. This programme focuses on developing expertise in regulatory compliance, submission procedures, documentation standards, and the ethical and legal requirements necessary for the development, approval, and marketing of pharmaceutical products.
Learners undertaking this diploma will explore a wide range of topics, including regulatory frameworks, clinical trial authorisation, pharmacovigilance, quality management systems, and international guidelines governing pharmaceutical operations. The course emphasises practical application, enabling learners to effectively interpret regulations, ensure compliance, and contribute to the safe and ethical distribution of medicines.
This qualification is aimed at professionals who wish to enhance their career prospects, expand their knowledge, and strengthen their commitment to Continuing Professional Development (CPD). By completing the programme, learners gain the skills required to take on roles in regulatory affairs, quality assurance, compliance management, or pharmaceutical project coordination, while supporting regulatory submissions and ensuring alignment with international standards.
Centres delivering this qualification must uphold high standards of training by employing competent and qualified staff with relevant expertise in pharmaceutical regulatory affairs. They are also required to provide all necessary learning materials, facilities, and resources to ensure learners receive a structured and high-quality learning experience.
By undertaking the LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs, learners take an important step towards advancing their professional careers, strengthening their regulatory knowledge, and contributing to the safe, compliant, and effective delivery of pharmaceutical products globally.
Course Overview
Qualification Title
LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs (Dip Regulatory Affairs)
Total Units
6
Total Credits
60
GLH
240
Qualification #
LICQ2201162
Qualification Specification
To enroll in the LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs (Dip Regulatory Affairs) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201162-1 |
Introduction to Pharmaceutical Regulatory Affairs |
10 |
40 |
|
LICQ2201162-2 |
Regulatory Frameworks and Legislation |
10 |
40 |
|
LICQ2201162-3 |
Clinical Trials and Authorisation Procedures |
10 |
40 |
|
LICQ2201162-4 |
Pharmacovigilance and Safety Monitoring |
10 |
40 |
|
LICQ2201162-5 |
Quality Management and Compliance Systems |
10 |
40 |
|
LICQ2201162-6 |
Applied Regulatory Affairs Project |
10 |
40 |
By the end of this course, learners will be able to:
Unit 1: Introduction to Pharmaceutical Regulatory Affairs
By the end of this unit, learners will be able to
- Explain the fundamental principles of pharmaceutical regulatory affairs
- Describe the role and responsibilities of regulatory professionals in the pharmaceutical industry
- Analyse the impact of regulatory frameworks on the development, approval, and distribution of medicines
- Demonstrate understanding of compliance requirements in pharmaceutical practice
Unit 2: Regulatory Frameworks and Legislation
By the end of this unit, learners will be able to
- Explain national and international pharmaceutical laws, regulations, and guidelines
- Identify the roles and functions of regulatory authorities and organisations
- Analyse legal and regulatory requirements relevant to pharmaceutical products
- Apply regulatory principles to ensure compliance in pharmaceutical operations
Unit 3: Clinical Trials and Authorisation Procedures
By the end of this unit, learners will be able to
- Explain the regulatory requirements for clinical trials and authorisation of new medicines
- Analyse processes for obtaining clinical trial approvals and regulatory submissions
- Apply knowledge of authorisation procedures to ensure compliance with ethical and legal standards
- Evaluate regulatory documentation and reporting requirements in clinical research
Unit 4: Pharmacovigilance and Safety Monitoring
By the end of this unit, learners will be able to
- Explain the principles of pharmacovigilance and drug safety monitoring
- Apply procedures for adverse event reporting and risk management
- Analyse pharmacovigilance data to support regulatory compliance
- Demonstrate understanding of safety monitoring systems and ethical considerations
Unit 5: Quality Management and Compliance Systems
By the end of this unit, learners will be able to
- Explain the principles of quality management systems and standard operating procedures (SOPs)
- Apply auditing and monitoring techniques to ensure compliance in pharmaceutical operations
- Analyse regulatory compliance processes to identify areas for improvement
- Demonstrate understanding of quality assurance principles throughout the pharmaceutical lifecycle
Unit 6: Applied Regulatory Affairs Project
By the end of this unit, learners will be able to
- Plan and execute a regulatory affairs project addressing real-world pharmaceutical scenarios
- Apply regulatory knowledge to assess compliance, safety, and quality considerations
- Demonstrate problem-solving and analytical skills in regulatory decision-making
- Present project findings professionally, showing applied knowledge of pharmaceutical regulatory affairs
The LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs is ideal for
- Pharmacy professionals seeking to enhance their knowledge of regulatory affairs and compliance
- Healthcare practitioners and pharmaceutical scientists aiming to work in regulatory, quality, or compliance roles
- Graduates in pharmacy, pharmaceutical sciences, life sciences, or healthcare disciplines who wish to specialise in regulatory affairs
- Professionals involved in clinical trials, pharmacovigilance, or quality management who want to strengthen their regulatory expertise
- Individuals committed to Continuing Professional Development (CPD) and career progression within pharmaceutical regulatory environments
- Professionals aspiring to manage regulatory submissions, compliance audits, and regulatory strategy within the pharmaceutical industry
- Learners seeking practical skills to apply regulatory principles in real-world pharmaceutical scenarios
Centres delivering the LICQual Level 3 Diploma in Pharmaceutical Regulatory Affairs must meet high standards to ensure effective learning and successful outcomes for all learners. The following requirements should be in place:
- Qualified and Competent Staff
Centres must employ trainers, assessors, and internal quality assurers with relevant academic qualifications and professional experience in pharmaceutical regulatory affairs, quality management, or related healthcare disciplines. - Access to Learning Resources
Centres must provide up-to-date study materials, textbooks, digital resources, and case studies covering regulatory frameworks, compliance standards, pharmacovigilance, clinical trials, and quality management. - Practical Training and Applied Learning Facilities
Centres should provide facilities and tools to support practical exercises, case studies, simulations, and applied regulatory affairs projects. - Assessment and Quality Assurance Systems
Centres must implement robust assessment strategies and internal quality assurance processes to ensure reliability, consistency, and alignment with international standards. - Learner Support Services
Centres must offer academic guidance, mentorship, and access to Continuing Professional Development (CPD) resources to support learner engagement and success. - Technology and Digital Access
Centres should provide access to e-learning platforms, software tools, and digital resources to facilitate flexible and blended learning. - Commitment to Compliance and Continuous Improvement
Staff must engage in ongoing CPD, maintain up-to-date regulatory knowledge, and follow ethical and legal standards in pharmaceutical regulatory affairs education and training.
By meeting these centre requirements, training providers can deliver a high-quality, learner-focused programme that equips professionals with the knowledge, skills, and confidence to excel in pharmaceutical regulatory affairs and compliance.
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.
