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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.

  Back to Basics in Pharmacovigilance
     10/11 September 2008

     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

Serious Cardiac Arrhythmias with Medicines: A Population Perspective 18 September 2008

  Critical Appraisal of Medical and Scientific Papers:
     How to read between the lines
     24/25 September 2008

     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
     15/16 October 2008

     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

  Case Narrative Writing for Reporting Adverse Events
     12/13 November 2008

     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

  Pharmacovigilance in products subject to licensing agreements
     19/20 November 2008

     Programme outline:

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

Advanced Workshop & Round Table Meeting on Pharmacovigilance Planning and Risk Management 11/12 December 2008

DSRU 1st Biennial Conference on Pharmacovigilance Updates and New Frontiers 2009 - Date To Be Confirmed

  Medical Aspects of Adverse Drug Reactions
     28/29/30 January 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

Data Safety Monitoring Boards Either 14/15 January or 11/12 February 2009 TBC

Monitoring safety in clinical trials and drug development 25/26 February 2009

  Back to Basics in Pharmacovigilance
     11/12 March 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

  How to Operate Volume 9A
     1/2 April 2009

     Programme outline:

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

Compliance in pharmacovigilance and the role of the EU qualified person 13/14 May 2009

  Periodic Safety Update Reports (PSURs)
     3/4 June 2009

     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

  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

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