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DSRU runs a programme of short courses for basic training and competency skills through to more advanced topics.

These courses run annually and registrations are taken at any time.

  Medical Aspects of Adverse Drug Reactions
     8/9/10 July 2009

      Programme outline:

• Overview of ADRs and interactions
• Genetic and metabolic basis for ADRs
• Immunological aspects of ADRs
• ADRs by system organ class:
  • Cardiovascular
  • Dermatology
  • Endocrinology
  • Gastrointestinal
  • Haematology
  • Hepatic
  • Neuropsychiatry
  • Renal
  • Respiratory
  • Teratology and issues in pregnancy
• Regulatory aspects:
  • Interpretation/evaluation
  • Guidelines
  • Causality assessment

  Introduction to Pharmacoepidemiology
     15/16 July 2009

     This course has been developed for scientists working in industry, regulatory authorities or academia.
     It is suitable for those who have no previous training or experience in pharmacoepidemiology and
     those who have some basic knowledge and wish to develop it further.

     Programme Outline:

• Scope and purposes of pharmacoepidemiology
• Basic concepts
• Study methods
• Basic statistical tools
• Data Resources
• Applications of statistical methods
• Interpreting data
• Opportunities for further training

  Back to Basics in Pharmacovigilance
     9/10 September 2009

     Programme outline:

• Historical aspects and evolution of drug safety
• Regulatory aspects, including the Clinical Trial Directive and PDUFA III
• International Conferences of Harmonisation
• Collecting and reporting drug safety information
• Pharmacovigilance planning

  Critical Appraisal of Medical and Scientific Papers:
     How to read between the lines
     23/24 September 2009

     Programme outline:

• Sessions on basic clinical research, epidemiological and statistical concepts
• Sessions on finding and synthesising the evidence
• An overview of Evidence Based Medicine
• Workshops in Critical Appraisal

  Risk Benefit Assessment in Pharmacovigilance
     14/15 October 2009

     Programme outline:

• Principles of risk: benefit assessment and management
• Familiarity with CIOMS IV
• Evaluating signals
• Reporting and summarising safety data at registration and for the PSUR
• Variations, urgent safety restrictions, licence suspesion and withdrawal
• European procedures and PDFUA III
• SPCs and PILs
• Crisis management

  Interpretation of Laboratory Results in Pharmacovigilance
     Date to be confirmed



  Case Narrative Writing for Reporting Adverse Events
     11/12 November 2009

     This workshop is aimed primarily at people who are new to narrative
     writing but it may also be of interest to those who feel they need an update.

     Programme outline:

• Outline of data elements required for case narrative writing
• Style and skill involved
• Handling follow up information
• Dealing with difficult cases
• Incorporating narratives into -
  • clinical trial study reports
  • PSURs
  • regulatory safety summaries including CTD

Data Safety Monitoring Boards Date To Be Confirmed

  Pharmacovigilance in products subject to licensing agreements
     18/19 November 2009

     Programme outline:

• Nature and types of relationships
• Due Diligence
• Safety agreements
• Managing relationships/responsibilities
• Legal Perspective
• Compliance

Pharmacovigilance Planning and Risk Management 3/4 December 2009

  Medical Aspects of Adverse Drug Reactions
     January 2010 (TBC)

      Programme outline:

• Overview of ADRs and interactions
• Genetic and metabolic basis for ADRs
• Immunological aspects of ADRs
• ADRs by system organ class:
  • Cardiovascular
  • Dermatology
  • Endocrinology
  • Gastrointestinal
  • Haematology
  • Hepatic
  • Neuropsychiatry
  • Renal
  • Respiratory
  • Teratology and issues in pregnancy
• Regulatory aspects:
  • Interpretation/evaluation
  • Guidelines
  • Causality assessment

Monitoring safety in clinical trials and drug development February 2010

  Back to Basics in Pharmacovigilance
     March 2010

     Programme outline:

• Historical aspects and evolution of drug safety
• Regulatory aspects, including the Clinical Trial Directive and PDUFA III
• International Conferences of Harmonisation
• Collecting and reporting drug safety information
• Pharmacovigilance planning

  How to Operate Volume 9A
     April 2010

     Programme outline:

• Review of the content of Volume 9A
• Highlighting of the applications and approaches for compliance with Volume 9A
• Opportunities for interactive participation

Keeping Up With The Constantly Changing Global Regulatory Environment For Pharmacovigilance - Staying In Control May 2010

  Periodic Safety Update Reports (PSURs)
     June 2010

     Programme outline:

• History of PSUR's
• Format and content of a PSUR - the ICH E2C guideline
• Planning and writing a PSUR
• Summary bridging reports and addendum to PSUR
• CIOMS V group recommendations

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