General provisions

Substituting and corresponding earlier the course 3FG415 or 3FG700, Regulatory Requirements and Quality Assurance in Development and Manufacturing of Pharmaceutical Products.

Entry requirements

For applicants within the Master of Science Programme in Pharmacy, the student should have at least 150 credits from term 1 to 5 and have followed all earlier courses within the programme.

Learning outcomes

The students should on completion of the course:

- be able to find and use the sources to current information about the regulatory requirements that apply to development, documentation and approval of new drugs

- be able to describe the processes to receive approval for the use of drugs on man

- be able to describe and apply the quality system and working methods that apply to the preparation of drugs in pharmacies and in the industrial production of drugs and connected authority control

- be able to evaluate documentation of the production and control of drug

- be able to describe the basic requirements for activities within drug production as the qualified person

Content

As theme for the course consistently comes the regulatory framework for the development, documentation, production and approval of a new medicinal product will be treated step by step. Thus, the following parts will be treated:

1. Basic concepts about drugs, the pharmaceutical market, the pharmaceutical industry, the development process for new drugs, the approval processes and the supervision by the society. Drug distribution and retail trade.

2. Basic concepts as quality assurance, its different parts, GMP and GLP, GCLP, GCP, etc., will be defined and their role and aims within pharmaceutical activities be explained.

3. The different bodies of the regulatory system, The Medical Products Agency, EMEA, The European Commission and The Council of Europe. The relations between EU's regulations and the Swedish legislation and Sweden's participation in the international network. The role of pharmacopoeia in the control of the quality of drugs.

4. The principles for validation of analytical methods and manufacturing processes as well as requirements and methods for qualification of equipment for production of raw materials and final products.

5. Requirements regarding organisation, documentation, staff, premises and equipment for production of drugs.

6. General principles of the requirements on clinical trial and approval of new drugs of EU, FDA and ICH and the different procedures for the approval of new drugs within EU.

7. The procedure for the approval of other pharmaceutical groups (herbal drugs, homeopathics etc.) and for other pharmacy related products for example medical-technical products.

8. The continuous follow-up control of approved drugs (central and national), 5-years approval, changes, information specification, epidemiological data etc. Adverse drug reports, WHO Collaborating Centre for international Drug Monitoring.

9. The supervision of the international market for raw materials, control medicines and common products. Internet sale. Control of marketing activities. The pharmacy system.

10. The companies responsibility regarding approved drugs: monitoring of adverse reactions, information, liability and insurance issues. Patents.

Instruction

The teaching is given as lectures, group exercises and study visits. Compulsory parts of the course: group exercises and study visits.

Assessment

Examination takes place at the end of the course. To pass the course is required, apart from passed examination (examination code), passed results of compulsory parts (examination code).

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Possibility to supplement failed compulsory part can be given at the earliest at next course and only in case of a vacancy.