Practical approaches to risk minimisation for medicinal productsThe Council for International Organizations of Medical Sciences (CIOMS) announces the publication of Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.
 
Medical science continues to bridge new frontiers with an ever-widening array of medicinal products to treat illnesses and health conditions.  No medicine is devoid of risk, however, and for that reason, it becomes paramount to appropriately manage all kinds of risks, from the very minor ones to those with serious adverse effects, with the objective being a positive balance of benefits to risks.  Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large.


Previous reports from CIOMS I – VIII provided practical guidance in some essential components of risk management such as terminology and  reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection.  Beyond the detection, identification, and characterisation of risk, “risk minimisation” is used as an umbrella term for the prevention or mitigation of an undesirable outcome.

Risk management always includes tools for “routine risk minimisation” such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects.   Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need “additional risk minimisation,” select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable.  Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimisation, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life. 

 

ISBN 978 92 9036 084 4

Prices:

  • Hardcopy paperback CHF 45
  • e-book pdf individual single copy CHF 45
  • e-book pdf corporate (country-level) unlimited copies CHF 450
  • e-book pdf corporate (regional/global-level*) unlimited copies CHF 900
  • e-book pdf govt/academia (country-level) unlimited copies  CHF 200
  • e-book pdf govt/academia (regional / global-level*) unlimited copies CHF 400

Citation of document:  Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.  Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014.
 
*Please observe that due to order requests, the definition for the unlimited copy options concerns a country-level license and that the price for global-level usage has been established as of 23 September 2014. 

The Council for International Organizations of Medical Sciences (CIOMS) announces the publication of Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX. 

 

Medical science continues to bridge new frontiers with an ever-widening array of medicinal products to treat illnesses and health conditions.  No medicine is devoid of risk, however, and for that reason, it becomes paramount to appropriately manage all kinds of risks, from the very minor ones to those with serious adverse effects, with the objective being a positive balance of benefits to risks.  Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large.

 

Previous reports from CIOMS I – VIII provided practical guidance in some essential components of risk management such as terminology and  reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection.  Beyond the detection, identification, and characterisation of risk, “risk minimisation” is used as an umbrella term for the prevention or mitigation of an undesirable outcome.

 

Risk management always includes tools for “routine risk minimisation” such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects.   Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need “additional risk minimisation,” select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable.  Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimisation, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

ISBN 978 92 9036 084 4

Prices: Hardcopy paperback                    CHF 45

e-book pdf individual single copy             CHF 45

e-book pdf corporate (country-level)

  unlimited copies                                CHF 450

e-book pdf corporate (regional/global-level*)

  unlimited copies                                CHF 900

 e-book pdf govt/academia (country-level)

  unlimited copies                                CHF 200

e-book pdf govt/academia (regional/

global-level*) unlimited copies              CHF 400

Citation of document:  Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX.  Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014.

 

*Please observe that due to order requests, the definition for the unlimited copy options concerns a country-level license and that the price for global-level usage has been established as of 23 September 2014. 

 

 

 

New Meetings

1st Working Group on DILI Meeting, Geneva, Switzerland, 27-28 April 2017

11th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 22-23 March 2017

CIOMS 84th Executive Committee Meeting, Geneva, Switzerland, 28 November 2017

 

Recent Meetings

83rd CIOMS Executive Committee/General Assembly Meeting, Geneva, Switzerland, 29 November 2016

10th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 6-7 September 2016

10th Working Group Meeting on Revision of CIOMS International Ethical Guidelines, Utrecht, Netherlands, 1-3 June 2016

8th CIOMS Working Group Meeting on Vaccine Safety, Accra, Ghana, 22-23 March 2016

9th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 15-16 March 2016

82nd CIOMS Executive Committee Meeting, Geneva, Switzerland, 8 December 2015

ISoP meeting, Prague, Czech Republic, 27-30 October 2015

8th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 24-25 September 2015

7th CIOMS Working Group meeting on Vaccine Safety, near Philadelphia, PA, USA, 21-22 September 2015

8th Working Group X on Meta-analysis, New Brunswick, NJ, USA, 1-2 July 2015

9th Working Group on Revision of CIOMS International Ethical Guidelines, Paris, France, 14-16 June 2015

th Working Group on MedDRA IWG, Chavannes-de-Bogis, Switzerland, 19-20 May 2015

8th Working Group on Revision of CIOMS International Ethical Guidelines, Vilnius, Lithuania, 22-24 March 2015

6th Vaccine Safety Working Group, Lyon, France, 18-19 March 2015 

ISoP Meeting, Mysore, India, 12-14 January 2015

 

WHO on Twitter

WHO The Framework was set up in 2011 to introduce greater equity and solidarity among nations when the next pandemic strikes #WHA70
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WHO #WHA70 delegates emphasized the importance of prioritizing and supporting global pandemic #influenza preparedness and response
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WHO The Framework is also an instrument that facilitates risk analysis & the expeditious, fair & equitable sharing of vaccines & other benefits
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WHO #WHA70 delegates reaffirmed the critical role played by the Pandemic #Influenza Preparedness Framework https://t.co/X8CrSPDb59
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WHO The Global Polio Eradication Initiative has also strengthened countries’ capacities to tackle other health issues #WHA70
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