What is the focus of clinical review?
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1 Workshop Radiopharmaceuticals, Bern, 12. September 2018 What is the focus of clinical review? Wild Damian, Mitglied Fachkommission für Radiopharmazeutika FKRP, Abteilungsleiter Nuklearmedizin Universitätsspital Basel Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse Berne Switzerland
2 Submission of clinical information Package insert (Fachinformation), Swissmedic does not require a patient information sheet Clinical documentation (Modul 5, Swissmedic information sheet) All details can be found in the Swissmedic information sheet, documentation for authorization of radiopharmaceuticals. Workshop Radiopharmaceuticals, Bern, 12. September
3 I. Clinical efficacy II. Unwanted effects III. Contraindications IV. Warnings and Precautions V. Interactions VI. Overdose VII. Indication VIII. Activity dose/administration IX. Procedures (imaging and therapy) X. Pharmacokinetics/pharmacodynamics benefit risk Workshop Radiopharmaceuticals, Bern, 12. September
4 Benefit-risk assessment FDA s benefit-risk framework Workshop Radiopharmaceuticals, Bern, 12. September
5 I. Clinical efficacy - benefit Requirements on clinical efficacy for Swissmedic authorization or approval Authorization of therapeutic radiopharmaceuticals (HMG Art 9) o Comparative, randomised clinical trial is mandatory orphan drug status has facilitation Authorization of diagnostic radiopharmaceuticals (HMG Art 9) o Risk/benefit assessment, sensitivity/specificity, examples of original scans Facilitated authorization of well established use radiopharmaceuticals (VAZV Art 27a) o Risk/benefit assessment, Swissmedic scientific advise recommended Temporary authorization of therapeutic radiopharmaceuticals (revhmg Art 9a) Access to new radiopharmaceuticals which are evaluated in clinical trials compassionate use o Clinical urgency: risk/benefit assessment, advanced comparative, randomised clinical trial with results available within 2 years Temporary approval of radiopharmaceuticals (revhmg Art 9b) Access to new radiopharmaceuticals which are evaluated in clinical trials single patient use o Clinical urgency: risk/benefit assessment Workshop Radiopharmaceuticals, Bern, 12. September
6 IV. Warnings and Precautions The packet insert must include specific instructions for patients of child-bearing age; pregnancy test is mandatory in these patients especially before receiving therapeutic activities of radiopharmaceuticals sexual activity of patients and their partners; e.g. effective birth control methods must be used for at least 6 months after receiving therapeutic activities of radiopharmaceuticals breastfeeding patients; e.g. ablactation after receiving therapeutic activities of radiopharmceuticals, suspending breastfeeding after receiving diagnostic activities of radiopharmaceuticals for a specified time period Workshop Radiopharmaceuticals, Bern, 12. September
7 VIII. Activity dose/administration The packet insert must include specific instructions for the handling of pregnant and breast feeding patients; these are normally contraindications, otherwise there must be a justification and detailed instructions for the dosing and administration of radioactivity to pregnant and/or breast feeding patients the administration of radioactivity to paediatric patients activity must be justified and activity calculation must be given according to the EANM dosage card (Version ) the administration of radioactivity to patients with reduced organ function, e.g. kidneys, liver etc. Workshop Radiopharmaceuticals, Bern, 12. September
8 IX. Procedures (imaging and therapy) The packet insert must include specific instructions for scanning the patient; e.g. specific preparation before scanning, recommended scanning time, instructions for reading the scans etc. treating the patient; e.g. required information before administration, specific preparation before treatment (e.g. kidney protection, nausea prophylaxis etc.), radiation safety instructions, treatment monitoring (e.g. recommended blood tests and interval of tests), handling of extravasation injury etc. Workshop Radiopharmaceuticals, Bern, 12. September
9 Objections in the clinical review - Period 2016 until now I. Clinical efficacy II. III. IV. Unwanted effects Contraindications Warnings and Precautions V. Interactions VI. Overdose VII. Indication VIII. Activity dose/administration 1 x correction of indication 3 x missing justification of dosage IX. Procedures (imaging and therapy) 4 x adding information about scan protocol/scan reading instructions X. Pharmacokinetics/pharmacodynamics Workshop Radiopharmaceuticals, Bern, 12. September
10 Questions? Workshop Radiopharmaceuticals, Bern, 12. September
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