The LICQual Level 3 Certificate in Pharmaceutical Regulatory Affairs (Cert Regulatory Affairs) is a specialised qualification designed for professionals seeking to enhance their expertise in the regulation and compliance of pharmaceutical products. This course equips learners with a comprehensive understanding of the legal, ethical, and regulatory frameworks that govern the development, approval, and distribution of medicines. It is ideal for individuals aiming to advance their careers, expand their professional knowledge, and strengthen their Continuing Professional Development (CPD).
Learners will explore key areas such as regulatory requirements, submission procedures, quality assurance, compliance monitoring, and the role of regulatory authorities in safeguarding public health. The programme combines theoretical knowledge with practical application, enabling learners to interpret regulations, manage compliance processes, and contribute to the safe and effective delivery of pharmaceutical products.
LICQual emphasises the importance of high-quality training. Centres delivering this qualification must have competent and qualified staff, along with access to all necessary materials and resources, to provide a structured, supportive, and engaging learning environment. This ensures learners gain the knowledge, skills, and practical experience required to succeed in their studies and professional roles.
By completing the LICQual Level 3 Certificate in Pharmaceutical Regulatory Affairs, learners not only enhance their professional expertise but also position themselves for new opportunities in regulatory affairs, compliance management, quality assurance, and pharmaceutical consultancy. This qualification is an essential step for committed professionals aspiring to excel in the rapidly evolving field of pharmaceutical regulatory affairs and make informed contributions to healthcare and patient safety.
Course Overview
Qualification Title
LICQual Level 3 Certificate in Pharmaceutical Regulatory Affairs (Cert Regulatory Affairs)
Total Units
6
Total Credits
60
GLH
240
Qualification #
LICQ2201130
Qualification Specification
To enroll in the LICQual Level 3 Certificate in Pharmaceutical Regulatory Affairs (Cert Regulatory Affairs) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201130-1 |
Introduction to Pharmaceutical Regulatory Affairs |
10 |
40 |
|
LICQ2201130-2 |
Regulatory Frameworks and Guidelines |
10 |
40 |
|
LICQ2201130-3 |
Compliance and Quality Assurance |
10 |
40 |
|
LICQ2201130-4 |
Regulatory Submission and Documentation |
10 |
40 |
|
LICQ2201130-5 |
Risk Management and Pharmacovigilance |
10 |
40 |
|
LICQ2201130-6 |
Professional Development and CPD in Regulatory Affairs |
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 principles and scope of pharmaceutical regulatory affairs
- Describe the role of regulatory authorities in ensuring medicine safety, efficacy, and quality
- Analyse the impact of regulation on pharmaceutical development and healthcare delivery
Unit 2: Regulatory Frameworks and Guidelines
By the end of this unit, learners will be able to:
- Identify national and international regulatory frameworks and guidelines governing pharmaceuticals
- Explain legislation relevant to the development, approval, and distribution of medicines
- Apply regulatory standards to ensure compliance in pharmaceutical operations
Unit 3: Compliance and Quality Assurance
By the end of this unit, learners will be able to:
- Explain the principles of compliance monitoring and quality management systems in pharmaceuticals
- Apply Good Manufacturing Practice (GMP) standards to operational processes
- Evaluate audit procedures and strategies for maintaining regulatory compliance
Unit 4: Regulatory Submission and Documentation
By the end of this unit, learners will be able to:
- Prepare and manage regulatory submissions and documentation
- Demonstrate knowledge of dossier preparation and record-keeping requirements
- Communicate effectively with regulatory authorities regarding product approval and compliance matters
Unit 5: Risk Management and Pharmacovigilance
By the end of this unit, learners will be able to:
- Identify risks associated with pharmaceutical products and operational processes
- Implement safety monitoring and adverse event reporting procedures
- Analyse strategies to ensure ongoing compliance and patient safety
Unit 6: Professional Development and CPD in Regulatory Affairs
By the end of this unit, learners will be able to:
- Reflect on personal practice and identify areas for professional growth in regulatory affairs
- Develop a plan for continuous professional development (CPD)
- Apply ethical principles and professional standards in regulatory decision-making and practice
This course is designed for professionals and learners who wish to enhance their expertise in pharmaceutical regulation, compliance, and quality management. It is particularly suitable for:
- Pharmacists and Pharmacy Technicians seeking to gain knowledge in regulatory affairs and compliance procedures
- Healthcare Professionals and Scientists involved in drug development, clinical trials, or quality assurance
- Regulatory Affairs Specialists and Analysts aiming to strengthen their understanding of national and international pharmaceutical regulations
- Learners pursuing Continuing Professional Development (CPD) to improve professional skills and career progression
- Professionals involved in pharmaceutical manufacturing, distribution, or consultancy requiring knowledge of regulatory frameworks and submission procedures
- Learners committed to ensuring patient safety and regulatory compliance through effective application of regulatory principles
This course is ideal for motivated learners who wish to combine theoretical knowledge with practical regulatory skills, preparing them for success in a wide range of pharmaceutical, healthcare, and compliance roles.
To ensure high-quality delivery and successful learner outcomes, centres offering the LICQual Level 3 Certificate in Pharmaceutical Regulatory Affairs (Cert Regulatory Affairs) must meet the following requirements:
- Qualified and Competent Staff: Centres must have instructors and assessors with relevant qualifications and professional experience in pharmaceutical regulatory affairs, compliance, or quality management.
- Comprehensive Learning Resources: Centres should provide access to up-to-date textbooks, regulatory guidelines, digital learning platforms, and practical tools to support effective teaching and learning.
- Safe and Adequate Facilities: Learning environments must be well-equipped, safe, and suitable for classroom instruction, practical exercises, and regulatory case study analysis.
- Assessment and Monitoring Systems: Centres must implement robust processes to assess learners’ theoretical knowledge, practical skills, and competency in accordance with LICQual standards.
- Access to Practical Learning Opportunities: Learners should have opportunities to apply regulatory principles to real-world scenarios, simulations, or case studies, reinforcing applied learning.
- Commitment to Quality and CPD: Centres must support continuous professional development for staff and maintain ongoing quality assurance processes to ensure learners achieve high-standard outcomes.
Meeting these requirements ensures that learners benefit from a structured, engaging, and professional learning experience, equipping them with the knowledge and skills necessary for career advancement 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.
