BADI members only
Events 2020 December 11, 2020 |Parallel Trade | Pro bono Digital event - фотоархив October 09, 2020 | Drug Regulatory Affairs – Update Training Course Registration | Sessions | Coffee break 14/07/2020 Events 2019
Topics: PRAC Activities – PV-Referrals: New Developments, Implementation of Results of Referrals; EU Regulation 2019/5 - Changes in the Penalty Regulation / PV- Fees for EMA; PASS - Additional risk minimization measures (aRMM) and additional pharmacovigilance measures (aPhVM) according to the RMP; Signal Detection, Validation, Confirmation - View of Industry; PRAC Signal procedures - overview of the Signal detection process at PRAC (confirmation and follow-up), the requirements for the companies and procedural aspects including possible measures like amendment of the product information/ Dear Doctor Letters (DHPC) - View of Regulator; PhV Audits and Inspections – Update; MAH processes for collection of Human Safety Information from marketing activities. Training of employees and third parties; PhV Referral;
Topics: Bulgarian Drug Legislation - Update; New pricing, reimbursement and HTA Policy & Challenges in Bulgaria; Advanced therapy medicinal products - Types, EU Regulatory Framework and challenges; Certification by a Qualified Person and Batch Release of medicinal products manufactured outside the EU;
Topic: GMP (Good manufacturing practice – Добра производствена практика)
Topic: Foundation skills in Regulatory Affairs - Introduction in marketing authorization procedures, market access of medicinal products, Pharmacovigilance
Topics: Data exclusivity, market protection, orphan and paediatric rewards; Compassionate Use – regulatory overview in the EU and the new introduced Bulgarian legislation; Oncology Drug Development – Key Regulatory Guidelines; |