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Risk Management Plan Workshop: Answers

Risk Management Plan Workshop: Answers. Postgraduate Course in Pharmaceutical Medicine Cardiff University Dr Peter Arlett - April 2012. Prepared by: Dr Daniel Becker EMA. Question 1: Answer.

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Risk Management Plan Workshop: Answers

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  1. Risk Management Plan Workshop: Answers Postgraduate Course in Pharmaceutical Medicine Cardiff University Dr Peter Arlett - April 2012 Prepared by: Dr Daniel Becker EMA

  2. Question 1: Answer • Is Thalidomide induced teratogenicity an Important Identified Risk, an Important Potential Risk or an Important Missing Information? • Important Identified Risk

  3. Question 2 • Which populations should be targeted regarding Thalidomide induced teratogenicity?

  4. Question 2: Answer • Which populations should be targeted regarding Thalidomide induced teratogenicity? • female patients of childbearing potential • pregnant patients • male patients with partners of childbearing potential or with pregnant partners

  5. Question 3 • Which additional pharmacovigilance measures do you propose?

  6. Question 3: Answer • Which additional pharmacovigilance measures do you propose? • education of patients to report pregnancies immediately to their doctor • education of prescribers to to report pregnancies immediately to Celgene and the Competent Authority • special pregnancy reporting form sent to the reporter to find route cause of pregnancy prevention failure • pregnancy outcome form sent to the reporter at expected delivery date • expedited reporting of all pregnancies by the MAH to the regulatory authorities • cumulative analysis of all pregnancies in the PSURs

  7. Question 4 • Which routine risk minimisation measures do you propose?

  8. Question 4: Answer • Which routine risk minimisation measures do you propose? • Pack size limited to four week supply • SmPC section 4.2: Restricted medical prescription • SmPC section 4.3: Contraindications • SmPC section 4.4: Special warnings and precautions for use • black box warning • Package Leaflet • black box warning and patient instructions • Package labelling • warning and instructions in bold

  9. Question 5 • Which additional risk minimisation measures do you propose?

  10. Question 5: Answer • Which additional risk minimisation measures do you propose? 1) SmPC section 4.4: • prescription only valid for seven days • prescription of only four week supply for woman of childbearing potential • 2) Annex II of the marketing authorisation and product information – Conditions or restrictions with regard to the safe and effective use of the medicinal product: Educational material • Direct Healthcare Professional Communication before launch to all prescribing physicians and dispensing pharmacists • Healthcare professional booklet • Patient booklets • Patient cards

  11. Back-up slide Risk Management Plan Workshop 20 April 2011

  12. Question 6 • How would you measure the effectiveness of the risk minimisation?

  13. Bibliography • Thalidomide Celgene - EPAR - Product Information (http://www.ema.europa.eu)

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