Events 2019

  • 04.10.2019 – Pharmacovigilance, Part I – Module 1, Drug Regulatory Affairs – Update, Training Course 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;
Registration | Lecturers | Sessions | Coffee Break


  • 29.03.2019 - One Day Training Course, Free for BADI members

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;
Manufacturing: QP main responsibilities and challenges, PIC - Update; Most common GMP non-compliance in Bulgaria;
Registration | Lecturers | Sessions | Coffee Break

  • 08.04.2019 - One Day f2f Training Course

Topic: GMP (Good manufacturing practice – Добра производствена практика)
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  • 19.04.2019 - One Day f2f Training Course

Topic: Foundation skills in Regulatory Affairs - Introduction in marketing authorization procedures, market access of medicinal products, Pharmacovigilance
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  • 06.06.2019 – Annual Conference

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;
Variations: View of Industry  - Update; Variations of the MAs, regulatory requirements - BDA 10 years’ experience; Worksharing Variations – what’s the alternative?
New EU regulations for medical devices and IVD medical devices - Update;  Document Management System and Submission Management System - LORENZ docuBridge FIVE; How will IT influence Regulatory Affairs? IT-Projects at implementation and on the Horizon;
HTA changes in Bulgaria and HTA EU Landscape
Registration | Lecturers | Sessions | Coffee Break