A COURSE IN DRUG REGULATIONS Of the Bulgarian Association of Drug Information (BADI)

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A COURSE IN DRUG REGULATIONS Of the Bulgarian Association of Drug Information (BADI) on 11 and 25 October, 15 and 29 November, 6 December 2013 Venue Auditorium of the National Centrе of Infectious

Drug regulations are applied by pharmaceutical companies, regulatory authorities, contractual research organisations, etc.

adverse drug reactions. The programme of the course of drug regulations for 2013 consists of 5 modules of one day, on defined Fridays, in October, November and December 2013 г.

1 A COURSE IN DRUG REGULATIONS Of the Bulgarian Association of Drug Information (BADI) on 11 and 25 October, 15 and 29 November, 6 December 2013 Venue Auditorium of the National Centrе of Infectious and Parasitic Diseases (NCIPD), Yanko Sakazov Blvd. 26, Sofi[ 1504 Draft Programme With the participation of Bulgarian and foreign lecturers. Drug regulations are applied by pharmaceutical companies, regulatory authorities, contractual research organisations, etc. for the purpose of investigation, manufacture and marketing authorization, as well pharmacovigilance related to the associated with the risks associated with medicinal products and prevention their adverse drug reactions. The programme of the course of drug regulations for 2013 consists of 5 modules of one day, on defined Fridays, in October, November and December 2013 г. The programme is designed for students in pharmacy, medicine, biology or biochemistry, as well as for pharmacy assistants, who would wish to work in the regulatory offices in the pharmaceutical industry or regulatory authorities. The course is also suitable for experts, regulatory specialists and managers who already work in pharmaceutical companies, regulatory authorities and/or contractual research organisations and are willing to update and/or complete their knowledge on any module from 1 to 5 or all. This course is suitable for both beginners and advanced specialists in the trade since it completes specific knowledge in this field. What are the purposes of the course in drug regulations To make understand of the principles of pharmaceutical regulation at any stage of the development of medicinal substances prior to, during and after their marketing authorisation, as well as the role and responsibilities of the concerned parties in the EU regulatory process; 1

2 2. To make understand how legislation can help make continuous assessment of the benefit/risk ratio during the whole life-cycle of a medicinal product; 3. To analyse the critical points in the medicinal product regulation within the context the the EU medicinal product framework; 4. Use of the good regulatory practices for the improvement of environment; 5. To make understand the principles as to how to manufacture a medicinal product and compose the medicinal product dossier in this particular part; 6. Quality requirements and critical points in the part of the dossier relating to product quality associated with the development of the product and its maintenance sfter its release to market; 7. To present the main trends and to make understand the common principles of the UE legislative framework including Bulgaria and the interrelationship between the regulatory institutions in the field of medicinal products; 8. To make understand the principles of tharmacovigilance in compleince with the legislation of December 2012 and the acting guidelines; 9. Principles of pricing and reimbursement in the EU Member states and in Bulgaria and the implementation of pharmacoeconomic approaches to their assessment; 10. To do practical drills in order to acquire understanding in the topics of Modules 1-5 and experience in team-working; 11. To accumulate knowledge which will be a privilege for beginning work in pharmaceutical industry representations, regulatory authorities and contractual research organisations; 12. A 2-day training course is included including practical exercises, enlarged EudraVigilance dictionary of medicinal products (XEVMPD); Fundamentals and introduction in pharmacovigilance; Collection and management of pharmacovigilance information during clinical trials; Collection and management of post-marketing pharmacovigilance information; Pharmacovigilance information to regulatory authorities; Assessment of pharmacovigilanceand product information; Pharmacovigilance and the other depatments of the company; Pharmacovigilance and contractual relations with third parties; Qualified person of pharmacovigilance (QPPV) in the EU; Procedure documentation and pharmacovigilance; Pharmacovigilance inspections; XEVMPD 13. The modules will be handled by two or three or more lecturers throughout the day who will distribute the themes between themselves. 14. The lecturers will be from universities, regulatory authorities and the industry both in Bulgarian and abroad and their manes will be additionally listed. 15. Some of the lectures will be delivered in the English language without simultaneous translation. ================================================================= 2

3 PROGRAMME OF THE COURSE Module 1-11 October Introduction in pharmaceutical regulations, regulatory authorities and the Centralised Procedure Introduction in the course for pharmaceutical regulations Assoc. Prof. T. Benisheva, DSc., MD Regulatory documents and search of objective and reliable regulatory information; major sources of information Assoc. Prof. T. Benisheva, DSc., MD. 2. Normative documents and search for objective and reliable information.; major sources of information. European competent authorities in the field of pharmaceuticals: EMA major obligations, committees and the European Commission. 3. Authorisation regimes: types, general concepts and regulatory requirements T. Benisheva Coffee break The Centralised Procedure, timelines and quidelines R. Sharenkova, Actavis, 1h. 2. Medicinal products for rare diseases Maria Kamusheva, Faculty of Pharmacy, MU Sofia, 0.5 h. 3. Pediatric medicinal products Assoc. Prof. D. Dobrev, Faculty of Pharmacy, MU Sofia., 0.5h Lunch break Transparency in ЕМА procedures and ethical aspects T. Benisheva, 0.15h 2. Advertising of medicinal products in Bulgaria Prof. Valentina Petkova, Faculty of Pharmacy, MU Sofia, 0.45h. 3. Professional information and product packaging - QRD template practical approaches Rayna Kostova, B. Braun, 0.45h Coffee break Working groups Practical drills (test) ================================================================= Module 2 25 October Marketing authorisation regimes for release to market of medicinal products 2. Quality of medicinal products The National Procedure industry point of view R. Sharenkova, Actavis, 0.5h. 2. Generic and innovative medicinal productsfrom authorisation regime point of view, Assoc. Prof. Henri Astrug, Faculty of Pharmacy, MU Sofia, 1h 3

4 3. Falsified medicinal products Stella Shekerdjiyska, SANOFI Aventis, 0.5h Coffee break The Mutual Recognition Procedure and the Decentralised Procedure industry point of view, Detelina Gigova, Pfizer, 0.5h 2. Coordination group and interaction with PRAC, Petya Grueva and T. Benisheva, 0.5h Lunch break Prof. N. Lambov, Milen Dimitrov, MPharm., Faculty of Pharmacy 1. Development of medicinal active substances and medicinal products 2. ICH Q8, Q9, Q10 main directions; 3. Active medicinal substance, synthesis and characteristics. Quality systems for medicinal products 4. A medicinal product 5. Quality medicinal active substance and medicinal products 6. Control of a medicinal active substance and the medicinal product 7. Impurities and stability tests 8. Pharmacopoeia and Certificate by the European Pharmacopoeia (CEP) Coffee break 9. Quality system review concerning ICH Q9 and ICH Q10 Rossitza Rachinska, Unipharm, 0.5h. 10. Basic directions of EU-GMP Svetlana Tomova, Merck Serono, incl. points 10-12, 1h. 11. Risk management plan within quality management systems 12. Global quality dossier Module 3 of ectd structure and challenges; Practical approach (test) organised by lecturers ============================================================== Module 3 on 15 November :00 10:30 Nina Vankova Background and introduction to PV (0,5 h) The WHO and safety reporting CIOMS function and purpose ICH composition and guidelines Regulatory Authorities EU and non-eu Collection and Management of Safety Information for Investigational Products (1,0 h)nina Vankova The clinical development process drug safety participation in clinical trials documentation Drug safety during clinical trials EU regulations concerning safety data Management 10:30 11:00 Coffee-break 4

5 11:00 12:30 dr.maria Traikova Managing post-marketing safety information Adverse Drug Reactions Sources of safety information Drug Safety Database Drug Safety Information to Regulatory Authorities Adverse Drug Reactions reporting to Regulatory Authorities Expedited reporting in the EU requirements Electronic safety reporting - Eudravigilance database Periodic reporting in the EU - PSUR PSUR requirements for format and submission 12:30 14:00 Lunch break 14:00 Axel Thiele Phd The Pharmacovigilance System General requirements in the EU EU PV legislation Pharmacovigilance System Master File (PSMF) DDPS and switching to PSMF The Qualified Person for Pharmacovigilance (QPPV) in the EEA regulatory requirements Collection and Management of Safety Information for Marketed Products Risk management systems and RMPs Signal Detection Intensified Monitoring Referrals 15:30 16:00 Coffee-break 16:00 17:30 Exercises/discussion panel and test 16:00 17:30 XEVMPD exercises and test ================================================================== Module 4-29 November Pharmacovigilance, part Част 1І Post-release-to-market Pharmacovigilance ІІ Dr. Maria Traykova (Sopharma) and Dr. Borislav Borissov (Prescripcia) 9:00 10:30 Assessment of pharmacovigilance information and product information (1,5 h) Definition of a signal Regulatory requirements to the detection of signals; Sources of signals Qualitative and quantitative methods of detection of signals 5

6 Assessment of signals and the benefit/risk ratio Development and maintenance of basic corporate product information and/or basic corporate pharmacovigilance and product information 10:30 11:00 Coffee break 11:00 12:30 Pharmacivigilance and the other departments of the company(1 h) Corporate responsibilities as regards pharmacovigilance Science, development and pharmacovigilance Regulatory activities and pharmacovigilance Product quality and pharmacovigilance; Quality assurance and pharmacovigilance; Legal and commercial functions and pharmacovigilance Pharmacovigilance and contractual interrelations with third parties (0,5 h) Scope of the contractual agreements as regards pharmacovigilance; Regulatory requirements to contractual agreements Contractual agreements between pharmaceutical companies Contractual agreements with service providers as regards pharmacovigilance; Development and maintenance of pharmacovigilance agreements 12:30 14:00 Lunch break 14:00 15:30 Qualified person for pharmacovigilance (QPPV) in the ЕО (0,5 h) Main requirements to the QPPV. Responsibilities of the QPPV. How companies must support the QPPV. Local pharmacovigilance contacts. Procedural pharmacovigilance documentation (1 h) Basic pharmacovigilance documentation (PSMF) Detailed descriptions of the pharmacovigilance system (DDPS) and transition to PSMF Purpose and scope of standard operating procedures (SOP) Types of procedural documents Development of procedural documents Control of procedural documents 15:30 16:00 Coffee break 16:00 17:30 Pharmacovigilance inspections (0,5 h) Purpose and scope of regulatory inspections in the EU. Preparation for a pharmacovigilance regulatory inspection. Conduct of a pharmacovigilance regulatory inspection. 6

7 Report of a pharmacovigilance regulatory inspection. When things do not go well. Corrective actions after a pharmacovigilance regulatory inspection. Exercises and test Module 5-6 December Prices and reimbursement of medicinal products Health technology assessment general concepts implementation and work of the EU authorities with ЕМА Prof. G. Petrova, Faculty of Pharmacy, MU Sofia. 2. Health technology assessment from regulator s point of view Assoc. Prof. Alexandra Savova, National Council for Prices and Reimbursement of Medicinal Products (NCPRMP). 3. Prices and positive drug list from industry point of view Gergana Pavlova, Pfizer Coffee break Challenges in the implementation of legal rules on prices and reimbursement representative of NCPRMPPrices and positive drug lists from the regulator s point of view Prof. I. Getov 2. Prices and positive drug lists from the industry point of view Gergana Pavlova, Pfizer Lunch break Regulatory practices in the EU in the field of pricing and reimbursement R. Vassileva, NCPRMP. 2. Proposals for future steps for optimisation of the pricing and reimbursement procedures in Bulgaria Assoc. Prof. T. Benisheva, NCPRMP Coffee break Test Delivery of certificates - =================================================================== General information for the participants 1. Programme duration The programme consists of 5 consecutive Fridays of October, November and the beginning of December 2013 when everyone can also attend separate modules at his/her own discretion This course/module will enhance your knowledge, update it on the state-of-the-art requirements and provide contacts in this field with representatives of the regulatory departments of pharmaceutical companies if you wish to further develop yourself professionally. Modules 1 and 2 are focused on marketing authorisation procedures for medicinal products in the EU including Bulgaria. Modules 3 and 4 are focused on pharmacovigilance prior to and after release to market. Module 5 is focused on pricing and reimbursement. 7

8 The programme on pharmaceutical regulation with focus on pharmacovigilance has been developed by a team with experience in pharmaceutical regulation from the academic community of the Medical University Sofia, with representatives of the Faculty of Pharmacy and the Faculty of Public Health including experts from the pharmaceutical/biotechnological industry. 2. Who can apply for the said modules The modules can be attended by experts from the pharmaceutical industry as well as persons willing to enlarge their knowledge in one or more fields where they work with a view to acquiring knowledge and transition to other fields as well as to deepen their knowledge in the respective field. The modules as designated mainly for specialists with the corresponding degree of bachelor or master in medicine, pharmacy, biology or biochemistry who have or have no experience in these directions or possess relevant experience in the pharmaceutical/biotechnological industry. This course can also be attended by students in medicine, pharmacy as well pharmacy assistants, biologists and biochemists who are willing to focus to work in the pharmaceutical industry, regulatory authorities or contractual research organisations and have no or insufficient knowledge or experience in the said modules 1-5. Lack of qualifications is no barrier to enrollment, since the goal is to go into the matter of the above mentioned modules. Knowledge in these modules is a requirement for beginning work in the regulatory departments of pharmaceutical companies as well as in these organisations that deal in clinical trials. 3. Certicicates from the course: A certificate for pharmaceutical regulations will be awarded for all or selected modules. These certificates will confirm your qualification wherever it is required to warrant it. 4. Who wil be conducting the course: Professors in the MU-Sofia or experts from the pharmaceutical industry with long experience in the respective fields. All lecturers work within the frames of their field of teaching or are experts in their fields of practice. Foreign lecturers are also included. Actual learning activities include teaching, individual research, interactive discussions on case studies and each madule will end by a test where you get a result how you have taken it. Applications will be reviewed by order of receipt and the seats in the auditorium are limited. 5. Necessary requirements: In order to maintain the professional level of the programme, the applicants will be required to have as a minimum a bachelor degree or to be students who are nearing graduation (at the end of their education. Candidates who do not meet the entry requirements will be reviewed by the Managing Board on a case-by-case basis and will have a feedback through the Secretariate. The fees for BADI members and non-members are differentiated. The fees for students member and non-members are differenciated. Please, complete the registration form in block letters on on a computer. The registration form can be found on the BADI website, or drop a mail on: office@badibg. The Managing Board of BADI. 8

BULGARIAN ASSOCIATION FOR DRUG INFORMATION (BADI)

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