Diploma (Base Course) in Medicines Development

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1 INTRODUCTION The participation in PharmaTrain Project determines the design of the Master in Medicines Development, adapting the syllabus defined in the European project to the current needs of the Spanish pharmaceutical industry. The master comprises a Postgraduate Diploma in Medicines Development (Base Course) and it s also possible to take the modules independently. course Master in Medicines Development Diploma (Base Course) in Medicines Development AIMS OF THE MASTER DEGREE To provide training that has been agreed and validated at European level by universities and leading companies within the pharmaceutical industry. To provide the necessary knowledge on current legislation and its effects on the development of new drugs. To optimize the management and function of multidisciplinary and multidepartment teams for optimal development of new drugs. To prepare students to cope with the new challenges of biopharma companies. ORGANIZED BY Department of Pharmacology, Therapeutics and Toxicology, School of Medicine, Universitat Autònoma de Barcelona (UAB ) Fundació Doctor Robert- UAB In collaboration with Universitat de Barcelona and Universitat Pompeu Fabra DIRECTION AND COORDINATION Professor Magí Farré, Department of Pharmacology, Therapeutics and Toxicology, School of Medicine, UAB SPECIFIC COMPETENCIES At the end of the master the student will be able to: 1. Know the life cycle of the product, from the laboratory to the final customer 2. Lead and managing multi-disciplinary and multidepartmental teams for optimal development of new drugs 3. Cop with business and economic challenges of pharmaceutical industry. 4. Apply methodologies for the development of new drugs. 5. Apply tools and innovative strategies in the development of new drugs 6. Incorporate new successful drugs to market. With the collaboration of:

2 ACCREDITATION Master: 60 ECTS Students must take all courses and do a Master s Final Thesis for the master s degree. Diploma (Base Course): 30 ECTS Students who successfully completed the modules (from 1 to 6) to the value of 30 ECTS may be awarded the title of postgraduate certificate (Diploma). You can have an accreditation for each single Module TIMETABLE 1st course: from 2014/10/27 to 2015/07/18 2nd course: from 2015/12/14 to 2016/06/15 PARTICIPANTS One of the following qualifications will be required to access: medicine, veterinary medicine, pharmacy, dentistry, nursing, biology, biotechnology, biochemistry, chemistry, biomedical sciences or psychology. ADMISSION CRITERIA In addition to the admission requirements stipulated certain merits will be considered. Order of priority includes: Evidence of competence in English language to speak fluently and read technical texts Previous training in the field of drug development (documentary evidence). Experience in working in pharmaceutical and / or medical or academic research centres related to drug development. PROGRAMME CONTENTS The Master s Degree Programme takes two years. In the first year, the students must take six modules (each one of 5 ECTS, 30 ECTS in total). In the second year, students must take other three modules (each one of 5 ECTS, 15 ECTS in total) and the Master Thesis/Dissertation (15 ECTS). First year: M1 M2 M3 M4 M5 M6 Second year: M7 M8 M9 M10 MODULES SCHEDULE CODE MODULE TITLE DATE COORDINATOR FEE M1. M2. M3. M4. M5. M6. M7. M8. M9. M10. (*) To be confirmed Introduction to Pharmaceutical Medicine and Discovery of Medicines. 5 ECTS Non-clinical Testing and Pharmaceutical Development. 5 ECTS Exploratory and Confirmatory Development. 5 ECTS Clinical trials. Methodology and statistics. 5 ECTS Regulatory Affairs and Drug safety and Pharmacovigilance. 5 ECTS Pharmacoepidemioloy and Pharmacovigilance. 5 ECTS Biological and Advanced Therapies. 5 ECTS Healthcare Marketplaces, Economics of Healthcare. 5 ECTS Drug Development in Special Populations. 5 ECTS Master Thesis/Dissertation. 15 ECTS MODULE STRUCTURE Each Module has 2 parts: October 27 and 28, February 16, October 28 and 29, February 16, October 30 and 31, February 17, February 17 and 18, July 13, February 19 and 20, July 13, February 20 and 21, July 14, July 14 and 15, December 14, July 16 and 17, December 14, July 17 and 18, December 15, December 15 and 16, June 13, 14 and 15, 2016 The face to face part with a student workload of 1 ECTS. This part is scheduled in 12 hours at the beginning of the module and 4 hours at the end The online part with a student workload of 4 ECTS Andres G.Fernandez 900 Fèlix Bosch 900 Magí Farré 900 Xavier Carné 900 Cristina Avendaño 900 Laura Pellise* 900 Fernando de Mora 900 Pending 900 Josep Torrent- Farnell 900 Magí Farré 900 Face to face Online period Face to face 8 hours + 4 hours 4 ECTS (100 hours) Conclusions & Assessment 4 hours

3 SEQUENCING THE MASTER DEGREE 2014 September October November December 2015 January February March April May June July August September October November December 2016 January February March April May June Face to face M1 M2 M3 M4 M5 M6 M7 M8 M9 Online Master Thesis CONTENT FOR EACH MODULE M1 INTRODUCTION TO PHARMACEUTICAL MEDICINE AND DISCOVERY OF MEDICINES Face to face: October 27 and 28, February 16, 2015 Online dates: November, 2014 Introduction to Pharmaceutical Medicine An overview on the process of drug development at the pharmaceutical and biotechnological industry Discovery of Medicines Strategy and organisation of research. Collaborative approaches Disease models. Target discovery. Target validation. Receptor-based approaches Genomics. Proteomics. Omics Lead Discovery: New Chemical Entities (NCE) vs New Biological Entities (NBE). High Throughput Screening (HTS) Biochemical and cellular models Lead optimization Pre-clinical Pharmacology. Ratio PK/PD Principles of Translational Medicine. Relationship between animal and human pharmacology. Biomarkers. Project Management Techniques. R&D portfolio and resources planning M2 N O N - C L I N I C A L T E S T I N G A N D P H A R M A C E U T I C A L DEVELOPMENT Face to face: October 28 and 29, February 16, 2015 Online dates: December, 2014 Principles of non-clinical testing Preclinical studies Pharmacology Safety pharmacology Toxicology: acute, subacute and chronic Reproduction and genetic toxicology Pharmaceutical development Bases of drug formulation and pharmaceutica development of drug substances From pharmaceutical development to pharmaceutical manufacturing New tendencies in pharmaceutical innovation Planning clinical trials supply requirements

4 M3 E X P L O R ATO R Y A N D C O N F I R M AT O R Y DEVELOPMENT Face to face: October 30 and 31, February 17, 2015 Online dates: January, 2015 Clinical development Phases of clinical development Biomarkers Phase I Exploratory phase 0 clinicial trials Exploratory phase I clinical trials First in man Proof of concept in phase I Phase II and III Confirmatory phase II and phase III clinical trials Population pharmacokinetics Pharmacodynamic and pharmacokinetic modelling Go and no-go decisions in confirmatory phases M4 CLINICAL TRIALS. METHODOLOGY AND STATISTICS Face to face: February 17 and 18, July 13, 2015 Online dates: March and April, 2015 Clinical trial design Choice of interventional design. Placebo and active comparators. Observational studies Clinical trials conduct and interpretation Principles of Good Clinical Practices Principles of Ethics in Research Investigator brochure Master file Monitoring Adverse events Informed consent Interpretation of results Statistics Statistics analysis plan Superiority, equivalence and non-inferiority statistics Systematic review and meta-analysis M5 REGULATORY AFFAIRS AND DRUG SAFETY AND PHARMACOVILANCE Face to face: February 19 and 20, July 13, 2015 Online dates: April and May, 2015 Regulatory affairs Medicines regulations The approval process Regional differences in registration Drug Safety and Pharmacovigilance Adverse drug reactions Drug Safety Pharmacovigilance Pharmacoepidemiology Risk plan M6 PHARMACOEPIDEMIOLOY AND PHARMACOVIGILANCE Face to face: February 20 and 21, July 14, 2015 Online dates: May and June, 2015 Pharmacoepidemiology Epidemiology applied to pharmacoepidemiology Types of studies Statistics applied to pharmacoepidemiology Pharmacovigilance Epidemiology applied to pharmacoepidemiology Adverse drug reactions and drug Safety evaluation. Risk plan Types of studies Statistics applied to pharmacovigilance

5 M7 BIOLOGICAL AND ADVANCED THERAPIES Face to face: July 14 and 15, December 14, 2015 Online dates: Setember, 2015 M9 DRUG DEVELOPMENT IN SPECIAL POPULATIONS Face to face: July 17 and 18, December 15, 2015 Online dates: November, 2015 Biotechnology Principles of biotechnology Biotechnology in medicines development Development of biologics and advanced therapies Development of biologic proteins Biosimilars Cell therapy Gene therapy Other advanced therapies Development in special population Development in pediatrics Development in geriatrics Development in pregnancy Development in other special populations Orphan drugs Regulation of orphan drugs Development of orphan drugs M8 HEALTHCARE MARKETPLACES, ECONOMICS OF HEALTHCARE Face to face: July 16 and 17, December 14, 2015 Online dates: October, 2015 Life-cicle management Marketing medicines Product information Regulations Economics of health care Health economics evaluations Principles of pharmacoeconomics Pricing and reimbursement TFM MASTER THESIS/ DISSERTATION Face to face: December 15 and 16, 2015 Online dates: January, February, March, April, May and June, 2015 Master Thesis Oral Presentation: June 13, 14 and 15, 2016 Students can develop one of the following ways: Projects related to any of the content developed throughout the programme. Comparative studies of different contexts The Master s Director will assign a mentor for each student according the subject chosen. During the period scheduled there will be tutorials to help students with the assignment. The tutorials will be based on partial deliveries of the master s thesis and reflective exercises within the established terms. In addition the student will be asked to develop written and oral presentations for the Master Thesis Court constituted in accordance with the university regulations. The Master Thesis assessment will consider: Originality / Innovation: 20% Methodological rigor: 30% Oral presentation: 20% Applicability / Utility: 30%

6 MASTER EVALUATION Continuous assessment based on the study and analysis of clinical and business management cases related to the development of new drugs At the end of each module there will be a written assessment based on cases or MCQs Module name Weight for the final score M1 8% M2 8% M3 8% M4 8% M5 8% M6 8% M7 8% M8 8% M9 8% Final project 28% REGISTRATION FEE Master: Diploma (Base Course): Each single Module: 900 Maximum: 20 participants Registration Deadline: September 30, nd option of Registration: October 17, 2014 only if there is availability and depending on the Master s Direction acceptation. TO GET REGISTERED 1) Fill up the FORM to make your preregistration 2) Send by Post the requested documents (Master and Base Course): Photocopy of your identity card Certified photocopy of the University degree diploma One passport-size picture Send by Post Photocopy of your identity card (Module) 3) Send the proof of payment by to: PROGRAMME WEBSITE FURTHER INFORMATION Fundació Doctor Robert Edifici UAB-Casa Convalescència Sant Antoni Maria Claret, Barcelona. Spain Tel Fax joana.dalmau@uab.es Secretariat of the Fundació Doctor Robert joana.dalmau@uab.es PAYMENT SCHEDULE 1 st Payment due October 1, 2014: nd Payment due February 28, 2015: rd Payment due October 1, 2015: th Payment due January 30, 2016: VENUE Casa Convalescència Sant Antoni Maria Claret, Barcelona, Spain