Обучителни събития 2018 г.:

30.03.2018  - Seminar - Topics: Cosmetic products - update, Food supplements - update; Foodvigilance and market surveillance; Metabolic syndrome -  prevention in men and women; Medicines with well-established use; GDPR Directive; Bioprinting, 3D and 4D printing in medicinal products

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01.06.2018 - Seminar - Regulatory Update - Brexit, Market Access (HTA); Off-Label Use of Medication for Children; Orphan Drugs;  Drug Supply - Falsified Medicinal Products – update

Program | Speakers | Moderators Mini workshops


26 - 28.09.2018 - Training course - Foundation Skills in Medical Information 2018 - Introduction to Regulatory Affairs, Preclinic, Clinical Trials, Medical Information and Market Access (HTA)

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18.10.2018 - Training course - Medical writing - изготвяне на досие на лекарствен продукт и ОЗТ

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19.10.2018 - Module 1, Drug Regulatory Affairs Update Training course

Topics: Market Access (HTA) in the different MSs (France, Sweden, Germany) and reimbursement decisions; Falsified Medicinal Products - update; New Medical Device Regulations: Regulation (EU) 2017/745; Regulation (EU) 2017/746; Drug Shortages; EU parallel trade - Shortages (framework challenges in Bulgaria); Good distribution practice (GDP) - overview and challenges; Regulatory update: Brexit Implications for the MAHs (innovative and generics) - follow up, part II

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02.11.2018 - Module 2, Drug Regulatory Affairs Update Training course

Topics: Pharmacovigilance: PRAC activities, New Developments and important recommendations in PV-Referrals - Critics and possible approaches; PASS experiences; Experiences with the implementation of the EudraVigilance System launched on 22 November 2017, for centrally reporting and monitoring of suspected adverse reactions; European PHv-Law, The EU-Pharmacovigilance System, PSMF, QPPV, Assessment of Pharmacovigilance Information; Access Policy; Signal Detections, PHV-Inspections. Activities with Educational materials in Germany: “Blue Hand”; Roles and responsibilities of Sponsor/MAH and safety service provider

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09.11.2018 - Workshop - eCTD One Day f2f Training Course

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23.11.2018 - Module 3, Drug Regulatory Affairs Update Training course

Topics: Pharmacovigilance: Functionality of EVDAS; PSMF; MLM; Vaccine Safety; Registration Process in Eudravigilance Data Base and responsibilities of sponsor and their representatives; Be more successful at quality checks with analysis of audit questions; Cannabis for medicinal use - regulatory perspective, applicatons in medicine, legal framework.

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