Risk management plan workshop answers
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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

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

Question 1: Answer

  • Is Thalidomide induced teratogenicity an Important Identified Risk, an Important Potential Risk or an Important Missing Information?

    • Important Identified Risk


Question 2

Question 2

  • Which populations should be targeted regarding Thalidomide induced teratogenicity?


Question 2 answer

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


Question 3

Question 3

  • Which additional pharmacovigilance measures do you propose?


Question 3 answer

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


Question 4

Question 4

  • Which routine risk minimisation measures do you propose?


Question 4 answer

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


Question 5

Question 5

  • Which additional risk minimisation measures do you propose?


Question 5 answer

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


Back up slide

Back-up slide

Risk Management Plan Workshop

20 April 2011


Question 6

Question 6

  • How would you measure the effectiveness of the risk minimisation?


Bibliography

Bibliography

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


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