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11.2. Other requests None 12. Organisational, regulatory and methodological matters 12.1. Mandate and organisation of the PRAC 12.1.1. PRAC working group - Recommendations on efficiency of plenary meetings – best practice guide PRAC lead: Martin Huber, Rafe Suvarna, Ulla Wändel Liminga Action: For discussion 12.2. Coordination with EMA Scientific Committees or CMDh 12.2.1. Advancing the Development of Paediatric Therapeutics (ADEPT): successes and challenges of performing long-term paediatric safety studies – report from the FDA public workshop held in April 2016 Action: For discussion 12.2.2. Joint Paediatric Committee (PDCO)-PRAC Working Group - guideline on conduct of pharmacovigilance for medicines used by the paediatric population - proposal for creation of new GVP chapter for special populations Action: For discussion 12.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups 12.3.1. Advisory Group on Summary of Product Characteristics (SmPC) - 2010-2015 activity report Action: For discussion 12.3.2. Vaccines Working Party (VWP) / PRAC: Stakeholders proposal for the implementation of the principles of passive enhanced safety surveillance (ESS) for the upcoming pilot seasons Action: For adoption 12.4. Cooperation within the EU regulatory network None 12.5. Cooperation with International Regulators None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/325452/2016 Page 48/52
12.6. Contacts of the PRAC with external parties and interaction with the Interested Parties to the Committee None 12.7. PRAC work plan None 12.8. Planning and reporting None 12.9. Pharmacovigilance audits and inspections 12.9.1. Pharmacovigilance systems and their quality systems None 12.9.2. Pharmacovigilance inspections None 12.9.3. Pharmacovigilance audits None 12.10. Periodic safety update reports (PSURs) & Union reference date (EURD) list 12.10.1. Granularity and Periodicity Advisory Group (GPAG) PRAC lead: Menno van der Elst; Margarida Guimarães Action: For discussion 12.10.2. Periodic safety update reports None 12.10.3. PSUR action group – roadmap for PSUR issues: Joint PRAC/CMDh recommendation paper on common understanding - finalisation PRAC lead: Margarida Guimarães; Menno van der Elst; Jolanta Gulbinovic Action: For adoption 12.10.4. Union reference date list – consultation on the draft list Action: For adoption of the revised list Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/325452/2016 Page 49/52
Page 1 and 2: 10 May 2016 EMA/PRAC/325452/2016 Pr
Page 3 and 4: 4.3.5. Fluoroquinolones: Ciprofloxa
Page 5 and 6: 6.1.5. Carbidopa, entacapone, levod
Page 7 and 8: 7. Post-authorisation safety studie
Page 9 and 10: 11. Other safety issues for discuss
Page 11 and 12: 1. Introduction 1.1. Welcome and de
Page 13 and 14: 4.1.3. Regorafenib - STIVARGA (CAP)
Page 15 and 16: 4.3.6. Gefitinib - IRESSA (CAP) - E
Page 17 and 18: 5.1.4. Darunavir - EMEA/H/C/004068
Page 19 and 20: PRAC Rapporteur: Julie Williams Sco
Page 21 and 22: 5.3.9. Crizotinib - XALKORI (CAP) -
Page 23 and 24: Scope: Update of sections 4.2 and 5
Page 25 and 26: In addition, update of section 5.1
Page 27 and 28: Scope: Evaluation of a PSUSA proced
Page 29 and 30: 6.1.20. Lopinavir, ritonavir - ALUV
Page 31 and 32: 6.1.32. Pandemic influenza vaccine
Page 33 and 34: Scope: Evaluation of a PSUSA proced
Page 35 and 36: 6.3.7. Desogestrel, ethinylestradio
Page 37 and 38: Scope: MAH's response to LEG 050 [v
Page 39 and 40: PRAC Rapporteur: Martin Huber Scope
Page 41 and 42: Action: For adoption of advice to C
Page 43 and 44: 7.5.3. Dolutegravir - TIVICAY (CAP)
Page 45 and 46: 8.3.3. Emtricitabine, rilpivirine,
Page 47: 8.3.15. Tafamidis - VYNDAQEL (CAP)
Page 51 and 52: 12.16. Community procedures 12.16.1

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