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Course Content

The syllabus is practice-based and not only reflects the growing complexity of carrying out global clinical research but covers the recent technological advances that have taken place in the industry and keeps abreast of the ever changing regulatory scene.

The following modules are offered:

First Year (60 credits)

Clinical Research Module (30 credits)

Sub-Module: Drug Development Processes

  • History of drug development.
  • Discovery and selection of compounds for human investigation.
  • Toxicological requirements.
  • Pharmacokinetics and pharmacodynamics.
  • Drug interactions.
  • Special populations; elderly, children, renal and hepatic insufficiency.
  • Bioequivalence, formulation and stability testing.
  • Phase I studies.
  • Clinical development programme planning.
  • Statistical principles in determining sample size, randomisation and analysis.

Sub-Module: Clinical Research

  • Good Clinical Practice and International Harmonisation.
  • Case report form design.
  • Role of Ethics Committees and Institutional Review Boards.
  • Informed consent.
  • Data Management including electronic transmission of data.
  • Quality assurance; quality control, audit and regulatory inspection.
  • Medical devices
  • Clinical research in emerging markets
  • Detecting and managing fraud.

Therapeutics Module (30 credits)

Sub-Module: Central Nervous System

  • Pathophysiology, aetiology and treatment strategies of diseases affecting the central nervous system.
  • Topics to be selected from: dementias; depression; schizophrenia; epilepsy; insomnia; Parkinson's disease and anxiety.
  • Clinical trial protocol design.
  • Patient selection criteria.
  • Ethical considerations.
  • Choice of subjective and objective measures.
  • Problems encountered in conducting clinical studies.
  • Role of carers in patient management.

Sub-Module: Respiratory Diseases

  • Pathophysiology, aetiology and treatment of respiratory disorders.
  • Topics to be selected from: asthma, chronic obstructive airways disease, emphysema, infections, cystic fibrosis.
  • Design of suitable protocols for carrying out clinical research in respiratory diseases.
  • Patient selection.
  • Choice of subjective and objective measures.
  • Particular problems of carrying out clinical research in patients with respiratory disease.

Second Year (60 credits)

Advanced Clinical Research Module (30 credits)

Sub-Module: Advanced Clinical Research

  • Communication skills and report writing
  • Project managment
  • Selection and management of clinical research organisations
  • Preparing contracts insurance and indemnity
  • Laboratory tests
  • Time and man management skills
  • Cross cultural communications.

Sub-Module: Regulatory Affairs and Pharmacovigilance

  • Regulatory requirements in Europe, the USA and Japan.
  • Regulatory requirements for biotechnology products, medicinal devices and veterinary products.
  • Regulatory requirements for the preparation, packaging, labelling and storage of clinical trial drugs.
  • Health economics; pharmacoeconomics and quality of life assessment.
  • Safety reporting.
  • Methods of monitoring drug safety.
  • Responding to drug safety alerts.
  • Postmarketing surveillance.

Complementary Therapeutic Module (30 credits)

Sub-Module: Cardiovascular Diseases

  • Pathophysiology, aetiology and treatment of cardiovascular diseases.
  • Topics to be selected from hypertension, ischaemic heart disease, arrhythmias, cardiac failure.
  • Design of suitable clinical trials.
  • Patient selection.
  • Choice of subjective and objective measures.
  • Problems likely to be encountered in clinical trials.

Sub-Module: Oncology and Immunology

  • Common malignancies including haematological malignancies, use of cytotoxics and symptom control.
  • Immunological disorders and their management including AIDS.
  • Ethics of conducting oncology trials.
  • Particular problems of carrying out clinical research in patients with malignancies and immunological disorders.

Third Year

Research Methods Module

  • Overview of research methods.
  • Planning a research project.
  • Literature searching and systematic reviews.
  • Quantitative and qualitative research methods.
  • Data collection and analysis.
  • Critical appraisal of published research articles.
  • Presentation skills (written and oral).

Dissertation (MSc only)

To complete the MSc programme students will be expected to successfully complete a dissertation of up to 20,000 words.

NOTE

The Postgraduate Board of Studies in Pharmacy reserves the right:

  1. to add or delete modules from the above list
  2. to determine which modules are offered in any academic year
  3. to determine the combinations of modules to be pursued by each participant in each year of the course

- providing that participants are informed of any changes at the beginning of the academic year.

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