MODULE 12 Regulatory affairs April 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES

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1 MODULE 12 Regulatory affairs April 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES

2 n DRUG REGISTRATION : EUROPEAN PROCEDURES AND INTERNATIONAL ENVIRONMENT Stéphane CALLEWAERT S. Callewaert will present an overview of the regulatory environment and medicines registration in the EU. European requirements and procedures will be compared to those of the FDA and Japanese authorities. Stéphane CALLEWAERT M.Sc., Molecular Biology, ULB, Manager Regulatory Policy, Worldwide Regulatory Affairs, GSK Vaccines n André LHOIR M.D., Medical Assessor, Federal Agency for Medicines and Heath Products, Belgium, Member of the Committee for Orphan Medicinal Products (COMP) of EMA DRUG REGISTRATION: SPECIAL ISSUES André LHOIR, Els VERSCHAEREN A. Lhoir will present the European Regulation 141/2000 concerning orphan medicinal products, that is intended to stimulate sponsors to develop medicinal products for the treatment of rare diseases. He will also describe the activity of the Committee for Orphan Medicinal Products (COMP) which is in place since April E. Verschaeren will present an update on the mutual recognition and decentralised procedures and the regulation of generics. Els VERSCHAEREN Pharmacist and hospital pharmacist, KUL, Federal Agency for Medicines and Health Products, Belgium

3 Daniel BRASSEUR M.D, paediatrician at the Brussels University Children's Hospital, Queen Fabiola and currently chair of the paediatric committee (PDCO) at the European Medicines Agency THE PAEDIATRIC REGULATION Daniel BRASSEUR D. Brasseur will present the Paediatric Regulation 1901/2006 which has dramatically changed the European research environment. Designing clinical trials in children, regulating their conduct, assuring deliverables and sound scientific outcomes are challenges not only for Industry but also Academia and Regulators. Ethics Committees and National competent authorities have also a say in such research. All these aspects are not centralized in a decision making process yet but many are discussed at the EU-level by the Paediatric Committee of the EMA. PREPARATION OF A NEW DRUG APPLICATION - COMMON TECHNICAL DOCUMENT - SUMMARIES AND OVERVIEWS Anne HEPBURN The various parts of an application for a new chemical entity will be reviewed: summary of product characteristics, expert reports, analytical part, toxico-pharmacological part and clinical part. From July 1, 2003, all new licensing applications in Europe must be made using the Common Technical Document (CTD) format. This seminar will first give a rapid overview of this registration dossier. A more lengthy review of Module 2, as defined in the EU Notice to Applicants, will be made. This module contains the Summaries and Overviews, which are roughly the equivalent of the EU Expert Reports as previously defined. These documents have an important role with respect to the assessment and interpretation of the information contained in the rest of the dossier which will be discussed. The legal aspects pertaining specifically to the documents in Module 2 need also to be taken into account and will be summarised. Finally the course will try to provide clues for understanding defects in the applications and improving the chances of approval. Anne HEPBURN Ph.D. in Medical Biology, ULB, Director scientific writing and regulatory affairs, 4Clinics Belgium

4 Koen BRUSSELMANS, Master in Bioscience Engineering, Ph.D. in medical sciences. Quality Assessor. Federal Agency for Medicines and Health Products, Brussels SPECIFIC REGULATORY ASPECTS OF BIOLOGICS Koen BRUSSELMANS This session will be devoted to the specific regulations of biologics in the European Union, including the biosimilars. MEDICAL DEVICES OVERVIEW FROM MANUFACTURER TO PATIENT Augustin COPPEE Medical devices, in vitro diagnostics, medical imaging equipment depict more than 500,000 products available today at home, at the doctor s office, at hospital and nursing homes. Among others: pacemakers, implants, contact lenses, HIVtest, MRI scanners, bandages, scalpel, This high diversity of products are used to ensure health in individuals suffering from a wide range of conditions. This fast growing industry is unique and is unfortunately assimilated to the drug industry. Singular aspects such as market structure, market access, products lifecycle, learning curve, need to be put in perspective in order to understand this fascinating industry offering tremendous benefit to patients. On the one hand, this lecture aims to give an overview of what is a medical device and what are the major steps to access the market. On the other hand, this lecture also aims to discuss concept such as vigilance, traceability and finally to approach the description of some hybrid products. Augustin COPPEE Graduate in "Healthcare Management, Economics and Policy", SDA Bocconi, Milano. Advisor, Minister of Social Affairs and Public Health, Brussels

5 Wednesday 26 April 2017 Thursday 27 April Welcoming participants Stéphane CALLEWAERT Drug registration European and international environments Stéphane CALLEWAERT Drug registration European and international environments Coffee break Daniel BRASSEUR The paediatric regulation André LHOIR Orphan medicinal products Anne HEPBURN Preparation of a new drug application Coffee break Els VERSCHAEREN Decentralised & mutual recognition procedures and regulation of generics Lunch Koen BRUSSELMANS Specific regulatory aspects of biologics Auguste COPPEE Medical devices overview from manufacturer to patient

6 REGISTRATION FEES FOR THE COURSE AND EXAMINATION Attendance to the 16 modules, access to all course notes on the private domain of our web site and examination: Attendance to 4 selected modules, access to all courses notes on the private domain of our web site and examination : Attendance to one individual module, with a copy of the course notes : 600 Examination only, with access to all course notes on the private domain of our web site : Second or third attempt at the examination : 200 Registration can be done at any time during the year. Registration to a module includes two lunches and beverage breaks. A discount can be offered to candidates who are neither employed nor sponsored by a biopharmaceutical company. Register by , by sending the completed registration form to pharmed@ulb.ac.be. Download the registration form on our web site Payment should be made upon receipt of our invoice. The courses take place in Brussels, in the Museum of Medicne, Route de Lennik Brussels. For more information please contact : REGISTRATION AND INFORMATION Mrs Bahija JELLOULI PHARMED ULB CP611 Route de Lennik, 808 B 1070 Bruxelles BELGIUM pharmed@ulb.ac.be - Phone :