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Freestanding Sub-Modules

The Sub-Modules listed below are offered on a freestanding basis. These sub-modules take place over a 2 day period and are charged at £640 each (2013-2014). In addition participants are expected to pay for their overnight accommodation. Sub-Modules attended on a freestanding basis are non-assessed, but a Certificate of Attendance is issued by The Cardiff School of Pharmacy and Pharmaceutical Sciences.

The following sub-modules are offered (dates and venues are shown in the course calendar):

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.

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.

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.

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.

NOTE

The Postgraduate Board of Studies in Pharmacy reserves the right:

  1. to add or delete sub-modules from the above list
  2. to determine which sub-modules are offered in any academic year
  3. to determine the combinations of sub-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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