1 European Association of Faculties of Pharmacy 2010 Annual Conference - Catania, June 24 - 26 The Experience with the Master Programme in Regulatory Affairs at the University of Lisbon Faculty of Pharmacy Jos Jos é é A. Guimarães Morais A. Guimarães Morais Faculdade de Farm Faculdade de Farm á á cia, Universidade de Lisboa cia, Universidade de Lisboa
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European Association of Faculties of Pharmacy
2010 Annual Conference - Catania, June 24 - 26
The Experience with the Master Programme in Regulatory Affairs at the
University of Lisbon Faculty of Pharmacy
JosJoséé A. Guimarães MoraisA. Guimarães MoraisFaculdade de FarmFaculdade de Farmáácia, Universidade de Lisboacia, Universidade de Lisboa
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Master Programme in Regulatory Affairs
• Why?– Regulatory affairs is a growing field with a close connection with
Pharmaceutical Sciences
• What for?– There is a growing need for experts and workers in this crucial
area for Pharmaceutical Industry
• How?– By means of an Advanced Master Programme Master after
Master existing since 2001 at the Lisboa Faculty of Pharmacy
• Background– Need and history of drug regulation
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MAJOR TOXICOLOGICAL ACCIDENTSMAJOR TOXICOLOGICAL ACCIDENTS
•• 5050’’s s -- penicilin/streptomycine injectable penicilin/streptomycine injectable -- Portugal Portugal •• Cholin derived neurotoxic amine used as an excipientCholin derived neurotoxic amine used as an excipient
– D.L. 41448 – QUALITY/SAFETY
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OTHER TOXICOLOGICAL ACCIDENTS OTHER TOXICOLOGICAL ACCIDENTS leading to withdrawal from the marketleading to withdrawal from the market
COXIB’s 2003 Anti Inflammatory Cardiovascular Acc.
nimesulide 2007 Anti Inflammatory Hepatotoxicity
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Evaluable Properties of a medicinal product
• Efficacy– A set of therapeutic properties demonstrable
through clinical trials for a therapeutic indication; clinical safety
• Safety– Knowledge on the animal toxicity non-clinical
that can be extrapolated to humans• Quality
– A set of chemical, physical and galenical properties that ensure the maintenance of the benefit/risk ratio of medicinal products throughout their therapeutic life time
Extension Directives: 89/342 /343/381: Immunologicals; Radio labelled; Blood derivatives; Homeopatics Extension Directives: 89/342 /343/381: Immunologicals; Radio labelled; Blood derivatives; Homeopatics
89/105 – Transparency: pricing and reimbursement; 91/356 – Good Manufacturing Practice89/105 – Transparency: pricing and reimbursement; 91/356 – Good Manufacturing Practice
Rational Use Directives: 92/25/26/27/28: Wholesale Distribution; Dispensing Status*; Labelling; PublicityRational Use Directives: 92/25/26/27/28: Wholesale Distribution; Dispensing Status*; Labelling; Publicity
Directive 2001/83Directive 2001/83
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Legislation History• Regulations in force
– 2309/93 – Establishes the European Agency and Procedures
• Centralised for Biotecnology and Innovators• Decentralised/Mutual Recognition
– Directive 93/39
– 540/95 – Pharmacovigilance • Variations to Marketing Authorisations *
– 541/95 – in centralised procedures– 542/95 – in decentralised and national procedures
•Revoked and replaced by Regulations 1084/2003 and 1234/2008
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Legislation History
• New Directives– 2001/83 – Replaces Directives
• 65/65; 75/318; 75/319 + Extension and Rational Use Directives
– Drug Regulation is a complex field closely related to the whole of Pharmaceutical Sciences, deserving a specialisation
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• Drug regulation in Europe encompasses the whole life cycle of a Medicinal Product, from research to utilisation
• In the last 30 years, the system developed in order to ensure quality/efficacy/safety of Medicinal Products available to the Public Health System
• A regulatory framework and guidelines dealing with assessment and control of Medicinal Products incorporate latest R&D achievements
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• To cover all aspects of drug regulation is a huge task challenging professionals within Industry and Health Authorities, thus the need for advanced education, prompting the existence of Master and PhD programmes in this area
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STUDY PLAN FOR DRUG REGULATORY AFFAIRS MASTER PROGRAMME
Trimester Curricular Units Lectures Discussion Hours/week ECTS
Introduction to Drug Regulation 30 0 3 5
Quality – Drug Substance 30 0 3 51stDrug Policy and Economics 30 0 3 5
08Abr /20:00‐21:30 1,5 L Health Systems and their development
15 Abr /18:00‐19:30 1,5 L Health System in Portugal
15 Abr /20:00‐21:30 1,5 L Challenges and sustainability of Health Systems
22 Abr/18:00‐19:30 1,5 L Drugs in the Health System
22 Abr /20:00‐21:30 1,5 L Drugs and the Health Market
29 Abr /18:00‐19:30 1,5 L International Drug Policy and Regulation in Health
29 Abr /20:00‐21:30 1,5 L European Drug Policy
06 Mai/18:00‐19:30 1,5 L Development of the European System for Drug Evaluation and Supervision
06 Mai /20:00‐21:30 1,5 L Drug Policy of Political Parties and Government
20 Mai /18:00‐19:30 1,5 L Drug Financing System in Portugal and Other EU Member States
20 Mai /20:00‐21:30 1,5 L Challenges and Future Trends
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General topics
Current challenges for Health Systems
Public Health reform
Contracts in Health Care
Drug price regulation: competitivenessDC and MR proceduresCentralised Procedure: an account 1995/05Future challenges in Drug Regulation
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Specific topics
Orphan DrugsNon-prescription drugsPaediatric DrugsNew Therapies in OncologyTissue EngineeringCurrent issues in Clinical InvestigationResearch in Medicinal Chemistry R&D opportunities in PortugalR&D in Pharmaceutical BiotechnologyNew tendencies in Biotechnology
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Thesis subjects
• Clinical Assessment of Medical Devices
• Non prescription Drugs – classification criteria and regulation
• Patient information – from Summary of Product Characteristics to Patient leaflets and clinical practice
• Orphan Drugs – regulation and applications
• Biosimilars – regulatory environment
• Counterfeit drug products – measures to be taken
• Paediatric medicines – regulatory framework
• Clinical trials – regulation in Europe
• Pharmacovigilance – the European system
• Quality management in Drug Regulation
• Off-label Use of Medicines
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Thesis subjects
• ADR reporting for cosmetics and other hygiene products
• Pricing and reimbursement policies in Europe
• Internationalisation of Portuguese enterprises
• Pre-clinical evaluation of Biotechnology products
• The generic market in Portugal
• Quality variations – regulation CE/1234/2008
• Medical devices – classification of border line products
• Maintenance of Marketing Authorisations for products with adverse safety profile
• Risk Management Plan for isotretinoine
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Master Programme in Regulatory Affairs
• Programme running since 2001 every 2 years with an average of 40 students
• Job opportunities– National Drug Agencies: INFARMED; AFSSAPS; MHRA– European Medicines Agency– Department of Regulatory Affairs – Industry
• Recognition by the Professional Body – Ordem dos Farmacêuticos– Specialisation in Drug Regulatory Affairs