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1 training programme in pharmaceutical medicine Regulatory affairs INFARMED, Lisbon january 2012

2 Regulatory affairs january 2012 LocaL: INFARMED, Lisbon curricular unit Leader: Hélder Mota Filipe, Pharmd, Phd curricular unit co-leader: Graça Freire, Pharmd Lecturers: Stephen W. Cook, Paula Costa, Dinah Duarte, Margarida Menezes Ferreira, Hélder Mota Filipe, Graça Freire, Rosário Lobato, José M. Sousa Lobo, Dina Lopes, Marta Marcelino, Ana Paula Martins, João Cristóvão Martins, Leonor Meisel, Judite Neves, Gonçalo Nunes, Mª João Oliveira, Margarida Oliveira, Fernanda Ralha, Sónia Ribeiro, Bruno Sepodes organisation: Masters in Pharmaceutical Medicine Post-Graduate course in Pharmaceutical Medicine Director: Luis Almeida, MD, PhD, FFPM Deputy Director: Bruno Gago, PharmD, PhD ua.pt) address: Health Sciences Department University of Aveiro Campus Universitário de Santiago Edifício III Aveiro Portugal Tel Fax

3 DAy JANUARy time Programme Lecturer 0. introduction 09h45-10h Overview & objectives Hélder Mota Filipe & Graça Freire (GlaxoSmithKline) 1. overview of the global regulatory environment 10h00-11h00 11h00-11h30 11h30-12h General principles of medicines regulation, and international (WHO, WMA, CIOMS) and national agencies Regulatory management systems in Europe, US, Japan and ROW; Portuguese special regulatory requirements The main EU regulatory bodies Portuguese contribution to the international regulatory environment 1.5. Role of harmonization: International Conference on Harmonisation (ICH Guidelines); EU harmonisation. FDA guidances and EMA directives and guidances. FDA Critical Path Initiative and recent CDER initiatives Coffee-break Sónia Ribeiro (European Medicines Agency) & Hélder Mota Filipe Dina Lopes 12h00-13h Pharmacopeas, INN José M. Sousa Lobo (Faculty of Pharmacy, University of Porto) 13h00-14h00 Lunch 2. Marketing authorisation 14h00-15h30 15h30-16h30 16h30-17h Marketing authorisation applications in major countries/regions (MAA, NDA/BLA, JNDA and CNDA) EU marketing authorisation procedures: centralized, mutual recognition/decentralized; national procedures; procedure flow, timings; regulatory stakeholders; specificities and major differences; Portugal role as Rapp/Co-Rapp and RMS The approval, appeal and referral processes; aspects of confidentiality, transparency and updating 2.4. Fast-track review (exceptional, conditional approval); programs for unmet medical needs (AUE) Abridged applications, line extensions 2.6. MAA dossier. Module 1 Product Information; Summary of Product Characteristics (SmPC) impact on commercial strategy; SmPC Guidelines 2.7. Labelling. Patient Leaflet; guidelines (readability, excipients ) and user testing; QRD Group Marta Marcelino Mª João Oliveira (Roche) Margarida Oliveira

4 DAy JANUARy time Programme Lecturer 3. Medicines for children - Paediatrics regulation 09h00-09h PIP and waiver Art. 46 of Regulation (EC) No 1901/2006 Dinah Duarte 09h45-10h30 4. advanced therapies (atmp), biotechnology and biological products Margarida Menezes Ferreira (CAT/EMA/ INFARMED) 10h30-11h00 11h00-11h45 Coffee-break 5. Medicines for rare diseases - orphan drugs 5.1. Orphan designation application; the Committee for Orphan Medicinal Products (COMP); Community Register of OMP; Orphanet Bruno Sepodes (COMP/EMA) 11h45-12h30 6. Generics and biosimilars Rosário Lobato (CAM/ Faculty of Pharmacy, University of Lisboa) 12h30-13h30 Lunch 13h30-14h30 7. Vaccines Stephen W. Cook (GlaxoSmithKline Biologicals, UK) 8. Herbal and homeopathic medicinal products 14h30-15h Regulatory framework; EU and national requirements Ana Paula Martins (HMPC/EMA/ INFARMED) 15h15-15h45 Coffee-break 9. cosmetics 15h45-17h Regulatory framework; EU and National requirements Judite Neves 10. Medical devices regulations The role of the competent authority and notified body EU, national regulation and global harmonisation Task Force Regulatory and Labelling requirements In vitro diagnostic medical devices Judite Neves

5 DAy JANUARy time Programme Lecturer 11. Post-licensing procedures 09h00-10h Life-cycle management. Variations, renewals Paula Costa (Bial) 10h30-11h Direct healthcare professional communication. Urgent safety measures Gonçalo Nunes (Gilead) 11h00-11h30 Coffee-break 12. Medicinal products for veterinary use 11h30-12h Regulatory framework; EU and national requirements Leonor Meisel 12h30-13h30 Lunch 13. Quality, standards, and inspections 13h30-14h30 14h30-15h00 15h00-16h Quality control, quality assurance and certification systems Manufacture and wholesaler licenses Qualified Person Control of active ingredients Coffee-break Internet sales Counterfeit medicines Parallel import Customer complaints Product defects and recall; product withdrawal procedures Regulatory Inspections Fernanda Ralha João Cristóvão Martins 16h closing remarks Hélder Mota Filipe & Graça Freire (GlaxoSmithKline)

6 Module objectives: To know and understand the global regulatory framework applicable to medicinal products and medical devices. To know the procedures for medicines marketing authorisation. To know the regulatory specificities of medicines for children, advanced therapies, biotechnology and biological products, orphan drugs, generics and biosimilars, vaccines, herbal and homeopathic products, cosmetics, medical devices, and veterinary products. To know how to execute tasks relative to licensing and post-licensing procedures in fulfilment of national and international regulatory requirements. To understand the quality control and assurance systems applicable to manufacturing, distribution and dispense of medicines. Learning outcomes of the Module: After module completion, the participant should be able to: Understand the general principles of medicines regulation and the role of national and international regulatory bodies. Know the regulatory management systems in place in Europe, United States, Japan and other countries, and identify Portuguese special regulatory requirements. Know the Portuguese contribution to the international regulatory arena. Understand the importance of international harmonisation of requirements and procedures. Recognize the requirements and procedures related to submitting a Marketing Authorization Application (MAA) in major countries/regions. Know the different types of marketing authorisation procedures in Europe (centralised, mutual recognition/ decentralised, and national procedures). Understand the approval, appeal and referral processes, and the criticality of confidentiality, transparency and updating. Know the fast-track review (exceptional, conditional approval) and the programmes for unmet medical needs (AUE). Know the contents and purpose of product information, namely the summary of product characteristics (SmPC), labelling and patient leaflet (PL). Know the specific regulation applying to marketing authorisation of medicines for children, advanced therapies, biotechnology and biological products, orphan drugs, generics and biosimilars, vaccines, herbal and homeopathic products, cosmetics, and veterinary products. Know the regulations applying to marketing and labelling of medical devices. Know the post-licencing procedures and life-cycle management. Understand the systems and functions aiming to adequately control and assure the quality of medicines during manufacturing, distribution and dispense of medicines, and know the role of the qualified person (QP). Know the legal context and contents of regulatory inspections. Endorsed by the Associação de Médicos Portugueses da Indústria Farmacêutica Accredited by the Ordem dos Farmacêuticos

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