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Course Content

Module 1

Discovery of New Medicines

  • The philosophy behind and the organisation of research. The principal innovative steps in discovering, modifying, assessing and patenting new chemical and biological compounds.
  • The laboratory and animal testing of new compounds and the correlation of animal with human pharmacology.
  • The selection of compounds for exploratory human investigation and planning initial development work to permit human exposure.

Module 2

Pharmaceutical Development

  • The economic primary production of new compounds and secondary production of research and market formulations.
  • The choice of formulations depending upon the characteristics of the compound and the intended uses of the product. The pharmaceutical labelling of products, including clinical trial stocks, and storage requirements.
  • The testing of formulations for bioequivalence, stability, impurity and incompatibility leading to a final specification.
  • Preparing matching placebo and competitor products, packaging of clinical trial stocks, planning clinical trial requirements, distributing supplies and disposing of remaining stocks.

Module 3

Clinical Developments

a. Design

  • Choice of trial design, of placebo and comparators, of patient population, of sample size, of locations, of randomisation, of end-points and of statistical analysis.
  • Protocol writing, record form production, adverse event monitoring, standard operating procedures, pre-trial inspections and orientation meetings.

b. Documentation

  • Options for data collection (manual and electronic) and standardisation.
  • Creation, maintenance and security of databases, software validation, and archiving.
  • Data management from clinical trials: corrections, computer capture, verification and extraction.

c. Analysis and Reporting

  • Assessment of violations, withdrawals, errors, bias. Analysis of efficacy end-points and of safety. Clinical interpretation of trial data.
  • Statistical principles and issues in report-writing: data manipulation, transposition, merging.
  • Final report writing and formatting for registration dossier and publications.

d. Monitoring

  • Principles of Good Clinical Practice and procedures applied in all stages of clinical trial process to subject protection, scientific validity and safety. Quality control procedures, quality assurance inspections, independent audits.

Module 4

Communicating With Our Customers: Information, Promotion or Education?

  • Investigational brochures before marketing and prescribing information after marketing for doctors, pharmacists and patients; the preparation, review and revision of these documents. Directives, codes of practice, and product liability issues.
  • Promotional policy and procedures. Advertising and mail ethics, control and approval. Representative training, material and aids.
  • Educational meetings, sponsored meetings and sponsored publications.

Module 5

International Regulatory Affairs, Legal and Ethical Issues

  • Philosophy of regulatory controls, practical impact on international bodies and national agencies, harmonisation.
  • The evolution of control mechanisms, differences between agencies.
  • Integration of regulatory affairs into the pre- and post-marketing planning and review of product strategy.
  • The principles behind the licensing of human investigations and of clinical trials and the practical requirements throughout the development process. The preparation and submission of marketing applications in major countries, the approval and appeal processes.
  • The legal background to the licensing of research, the patenting of compounds, and of the marketing of medicines. Indemnity to investigators and to institutions. The ethical review process and the consent procedures in biomedical research. Arrangements for compensation of healthy volunteers and patients in pre-marketing studies.
  • Contractual arrangements with investigators and contract research organisations.

Module 6

Pre-Clinical Safety Testing

  • The fundamental differences and similarities between the pharmacology and toxicology of compounds and their metabolites in animals and man and their qualitative and quantitative assessment.
  • The purpose of descriptive and quantitative in vitro and in vivo testing. The choice of and the predictive value of these tests for acute, chronic, reproductive and genetic toxicity.
  • Systemic toxicology, common mechanisms of damage to organs and their detection or elucidation.
  • The scheduling of toxicological tests, linked to development plans, to regulatory needs, to human and animal pharmacology, and intended clinical use and route(s) of administration.
  • The size, cost and administration of a toxicological programme, its data management and its quality assurance, and report writing.
  • The regular review of toxicology, its inclusion into clinical trial protocols and brochures, and the appropriate planning of and correlation with the clinical evaluation of potential and observed toxicity in patients.

Module 7

Medical Statistics

  • The purpose and fundamentals of statistics. Pre-trial decisions and specification. Variations in biometry, in population, in disease. Risk factors, confounding variables. Within-trial decisions, data management, extraction and manipulation.
  • The null hypothesis, type I and II errors, significance, power, paired and non-paired tests, parametric and non-parametric tests, confidence limits.
  • Handling of rating and visual analogue scales, patient diaries and laboratory values.

Module 8

Principles of Clinical Pharmacology

  • The pharmaceutical process (eg bioavailability, concentration effect relationships, compliance).
  • The pharmacokinetic process (ie basic pharmacokinetic concepts, simple pharmacokinetic calculations, data fitting and statistical moment analysis, absorption distribution metabolism and excretion.
  • The pharmacodynamic and therapeutic process. Pharmacological effect of drugs and translations of Pharmacological effects into therapeutic effects.

Module 9

Safety of Medicines and Pharmacovigilance

  • Principles of drug safety evaluation, classification of adverse reactions, hypothesis generation and testing, the advantages and disadvantages and principles of spontaneous reporting, monitoring strategies during the postmarketing period, methods used to evaluate signals, the principles of causality assessment, limitation of clinical trials.
  • Pharmacoepidemiological principles and methods, patient and case control studies and the principles of record-linkage.
  • Medical dictionaries and searching strategies.
  • Pharmacovigilance: monitoring drug safety in clinical practice, identification of drug safety hazards, actions to improve drug safety, responding to drug safety hazards, postmarketing, monitoring and decision making, lessons learned from previous problems, the pharmaceutical physician and drug safety.
  • Regulatory requirements for pharmacovigilance: UK, Europe and USA, International Harmonisation, CIOMS (I,II,III) in relation to drug safety.
  • Global assessment of drug safety including risk benefit.
  • Commercial consequences of drug failure: financial, personnel, image, corporate attitudes, responding to media hype. Preparation for, and handling of, the media in the event of a crisis, formulation of plans, overall objectives.

Module 10

Economics of Health Care, Pharmacoeconomics and Financial Management

  • Economics of health-care: marketing structure and competition, price negotiations, national and local formularies.
  • Measures of health-care, governmental policy and third party reimbursement.
  • Pharmacoeconomics: cost analysis and cost of illness studies, cost-minimisation and analysis, cost-effective analysis, cost benefit and cost utility analysis.
  • Health-related quality of life: the concepts and benefits, measurement of utility values, quality adjusted life years, the Rosser utility valuation matrix, discounting, health years equivalent, saved young life equivalent.
  • Health-status measures: sickness impact profile, medical outcome study, Nottingham health profile, choice of measuring instruments for use in clinical trials.
  • Role of socioeconomics in clinical drug research: socioeconomic evaluation studies in clinical trials, future strategic and regulatory requirements.
  • Management concepts: goals, strategies, tactics and operations, decision making in the clinical development of new medicines.
  • Management skills: management of time, projects and people, crisis management.
  • Financial management: budgeting and financial control, purpose of accounting, profitability and cash flows, fixed assets and depreciation, return on capital and other ratios, budgeting and financial controls.
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