Central Hotel Forum (Sofia, bul. "Tsar Boris III" 41)

Transcription

1 1 BULGARIAN ASSOCIATION FOR DRUG INFORMATION (BADI) With the kind support from the Medical University - Sofia, organizes its regular autumn course on Pharmaceutical Regulations on the following topics: Regulatory affairs of generics and of biological products - biosimillars, allergenes, vaccines Pharmacovigilance - part I Pharmacovigilance - part II Medical devices; HTA assessment in the reimbursement of medicinal products - terminiology and preparation of assessment - part I HTA assessment in the reimbursement of medicinal products - terminiology and preparation of assessment - part II Central Hotel Forum (Sofia, bul. "Tsar Boris III" 41)

2 2 Draft Programme Module 1 7 October :00-9:15 Opening 1. How to prepare generic dossier and bioequivalence 2. How to develop global generic - regulatory issue and perspectives 3. Regulatory affairs in allergens - EU requirements and guidelines 11:00-13:00 1. Regualtory affairs in biosimilar products 2. Marketing authorizations and variations vaccines - industry point of view 3. Challenges in vaccines supply. 4. PRIME EMA perspectives Module 2 21 October 2016 Pharmacovigilance - Part I 9:00-9:15 Fundamentals update in pharmacovigilance requirement acc. Article 57 of the Regulation (EC) 726/ 2004 Violeta Ilieva, Ekaterina Genova Ecopharm; Maria Doleva - Boehringer-Ingelheim EudraVigilance - forthcoming changes - Maria Doleva (0.5h) Eudravigilance Stakeholder Change Management Plan Maria Doleva (0.5h) XEVMPD Updates (0.5 h) 11:00-13:00 Collection and management of pharmacovigilance data after receipt of a marketing authorisation Violeta Ilieva, MPharm, Dr. Ekaterina Genova, MPharm Ecopharm; Maria Doleva - Boehringer-Ingelheim

3 3 MedDRA & New SOC Product Issues Maria Doleva (0.5h) EMA Guidance on Medication errors - Dr. Ekaterina Genova, MD and Violeta Ilieva, MPharm (1 h) EV and signal detection by MAHs - Maria Doleva (0.5h) Off label Use - EMA Guideline - Module VI Literature monitoring - MLM Service - Vili Topalova (0.5 h) PSURs - Dr. Vili Topalova, MD (0.5 h) The Black Triangle and Regulatory Requirements for Post-Marketing Studies Dr. Vili Topalova, MD (0.5 h) 13:00-14:00 Lunch break 14:00-15:30 Pharmacovigilance and communication (Media/PR) Dr. Eva Borissova, MD (1 h) Corporate responsibilities regarding the handling of safety relevant information Corporate procedures and algorhythm of actions in case of safety issues. Regulatory activities and pharmacovigilance. Pharmacovigilance and contractual interrelations with third parties Dr. Vili Topalova, MD - Lindeq Scope of contractual agreements as regards pharmacovigilance. Regulatory requirements relating to contractual agreements. Contractual agreements between pharmaceutical companies. Contractual agreements with service suppliers regarding to pharmacovigilance. Drawing up and maintenance of pharmacovigilance agreements. Test and Picture of the participants Module 3 11 November 2016 Pharmacovigilance - Part II 9:00-9:15 Opening Prof. Tatyana Benisheva- - Moderator Assoc. Prof. Dobriana Sidjimova - Moderator Pharmacovigilance system, PRAC scope and activities, Risk/Benefit Assessment, Role of the Authorities and EMA- Committees, Pharmacovigilance Inspections. Prof.Barbara Sickmuller - Moderator Regulatory authorities and requirements Axel Thiele - Germany Pharmacovigilance system

4 4 Pharmacovigilance master file system. QPPV Role of the Regulatory authorities. PRAC - role and functions Maria Popova MD- Bulgarian Drug Agency (BDA) GVP Updates GVP XVI - Addendum I - Educational Materials Maria Doleva (0.5h) GVP VI Upcoming Revisions Maria Doleva (0.5h) The Role of Pharmacovigilance Department within the Company Dr. Eva Borisova (1 h) The Marketing Department and Pharmacovigilance Product quality and pharmacovigilance. Quality assurance and pharmacovigilance. Legal and commercial functions relating to pharmacovigilance. Adverse Reactions vs. Technical Product Complaints and Combined Reports Real Examples - Dr. Eva Borisova (1 h) Definitions Assessment of pharmacovigilance information Axel Thiele - Germany Ongoing safety evaluation Regulatory requirements relating to signal detection. Assessment of signals and benefit/risk ratio. Risk management systems and risk management plans. Intensified monitoring. Referral procedures. 13:00-14:00 Lunch break 14:00-15:30 Axel Thiele - Moderator Ekaterina Genova - Moderator New Pharmacovigilance requirements for marketed products in the EU: PASS/PAES PSUR/PBRER Educational material Prof.Barbara Sickmuller Germany Procedural documentation, quality system and pharmacovigilance Vili Topalova MD - Lindeq Pharmacovigilance System Master File - development and maintenance Quality Management System (QMS) and control of procedural documents. Updated pharmacovigilance topics for discussion 15:30-16:00 Coffee break

5 5 16:00-17:00 Vili Topalova MD Moderator Pharmacovigilance inspections Axel Thiele - Germany Purpose and scope of inspections in the EU. Preparation for a pharmacovigilance inspection (Inspection readiness) Conducting a pharmacivigilance inspection. When things are not going well. Corrective actions after a regulatory pharmacovigilance inspection, CAPA handling Test and Picture of the participants Delivery of certificates Module 4 25 November 2016 Medical Devices update and pharmacovigilance HTA assessment in the reimbursement of medicinal products - terminiology and preparation of assessment - part I Medical Device update - industry point of view Medical Device - regulatory point view - BDA 11:00-13:00 How to prepare HTA assessment and what to consider HTA Patient perspective HTA analysis - regulatory requirements 13:00-14:00 Lunch 14:00 Test Module 5 2 December 2016 HTA assessment in the reimbursement of medicinal products - terminiology and preparation of assessment - part II

6 6 9:00 - Opening HTA assessment in the reimbursement of medicinal products - terminiology and preparation of assessment How to choose the comparator HTA analysis and how to prepare the assessment part I 11:00-13:00 Mathematical modelling HTA and challenges at the HTA assessments HTA analysis and how to prepare the assessment Part II Test and certificates delivery Aiming at maintaining a professional level in the program, it is required that applicants have at least a relevant bachelor degree or you are students who are nearing graduation at the end of their education. Applicants who do not comply with the requirements for participation in this course will be separately assessed by the Managing Board of BADI and will have a feedback by the Secretariat. Fees for members and non-members are differentiated. Fees for students and non-members are differentiated. Please, complete in block letters or on a computer the attached registration form for the course at BADI s website and sent it there: office@badibg.org For contacts : ,