Events 2019

  • 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