PHRM09003 2015 Regulation and licensing of Pharmaceutical and Biotechnology Products and Medical Devices

Discriminate between Investigational Medicinal Products and marketed products and their associated regulatory requirements.

Explain the regulatory aspects including GMP principles relating to the manufacture, testing, packaging and labelling and release of Investigational Medicinal Products and licensed products.

Assess the various types of clinical trial designs, clinical trials application process including the investigational medicinal product dossier (IMPD).

Defend the principles of Good Clinical Trial Practice and their purpose.

Categorise the IMPD information requirements relating to specific types of investigational medicinal products.

Interpret the European and Irish regulatory system relating to the manufacture, storage and supply of licensed medicinal products including the general structure of Directive 2001/83/EC as amended by 2004/27/EC and Directive 2001/82/EC.

Explain the main elements and organisation of the Application Dossier for marketing and manufacturing authorisation.

Appraise the roles and responsibilities of the qualified person, the manufacturer, the authorisation holder and wholesaler and regulatory agencies.

Open and Distance Learning (ODL) On-Line with limited on site activities of 20 hours workshop per semester

Continuous Assessment: 40 % (MCQ 20%, Assignments / essays 20%)

Final Written Examination: 60 %

As per IT Sligo Marks and Standards

The development process and regulatory requirements for a medicine

Good Manufacturing Practice for IMPs, human and veterinary medicines

Manufacture and controls of IMPs:

Systems for controlling active, placebo and comparator forms

Control of packaging operations and blinding

Effective batch documentation, sampling and batch release

Change control and material traceability

Clinical trial design and principles of Good Clinical Practice (GCP)

European pharmaceutical directives (including 75/319/EEC, 81/851/EEC, 89/381 /EEC, 91/356/EEC, 92/73/EEC)

Irish Legislation controlling the quality, and safety of medicinal products for both human and veterinary use, including Regulations Governing the Sale of Medicines and Poisons, Veterinary Medicines Legislation, and an introduction to the Control of Clinical Trials Act, 1987

Marketing and Manufacturing Authorisation requirements and responsibilities

Wholesale Dealers and Importers legislation (in particular Directive 92/25/EEC)

The role, legal status and structure of the European, British and US Pharmacopoeias

The organisation and role of the Irish Medicines Board and the role of the European Agency for the Evaluation of Medicinal Products (EMEA)

Summary of the role and function of the UK Medicines Control Agency (MCA), Veterinary Medicines Directorate (VMD), Food and Drug Authority (FDA) and World Health Organisation (WHO)

Procedures for dealing with product recall and the role of the HPRA's defective medicines reporting centre

Principles of the following:

• The International Conference on Harmonisation (ICH)
• Mutual Recognition Agreements
• Pharmaceutical Inspection Co‑operation Scheme (PICS)
• Product liability legislation

Ethics and the role of the Qualified Person

• EEC Directives concerning the nature, purpose and function of the QP
• The Code of Practice for Qualified Persons
• Responsibilities. liability and disciplinary procedures (MAL 45 and MAL 69)
• Contract manufacture requirements and the contents of a legal contract
• Preparation for and management of regulatory inspections
• Role of trade and professional organisations

Administration

• Legislation affecting employee relations and employment. The Safety, Health
• Welfare at Work‑ Act, 1989 and other relevant regulations for industrial premises
• Appreciation of the skills needed for the recruitment, training and management of people with special reference to GMP

Procedures for dealing with complaints