CLINICAL PHARMACOLOGY

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1 0 :: 2 v01 x y p.345 B xxx.:: B A x y pval«««[xy] -løøøø xxx.:: øøøø A PHARMATRAIN CENTRE OF EXCELLENCE EXPLORATORY & CONFIRMATORY CLINICAL DEVELOPMENT: CLINICAL PHARMACOLOGY Aveiro november, 2013 UCM 03

2 EXPLORATORY & CONFIRMATORY CLINICAL DEVELOPMENT: CLINICAL PHARMACOLOGY COLLABORATION Face-to-face course: november, 2013 MODULE LEADERS: Luis Almeida, MD, PhD Director of the Training Programme in Pharmaceutical Medicine; Invited Associate Professor, Health Sciences Department, University of Aveiro, Portugal. Managing Partner, Blueclinical Ltd. Teresa Nunes, MD, MSc, MBA Medical Director, PRA Phase I, The Netherlands LECTURERS: Amílcar Falcão, PharmD, PhD Inês Barbosa, BSc Luís Almeida, MD, PhD Silvia Sirgado Teresa Nunes, MD, MSc, MBA ORGANISATION: TRAINING PROGRAMME IN PHARMACEUTICAL MEDICINE A PharmaTrain CENTRE OF EXCELLENCE Director: Luis Almeida, MD, PhD Deputy Director: Bruno Gago, PharmD, PhD Associate Director: Miguel Forte, MD, PhD Health Sciences Department University of Aveiro Aveiro Portugal Tel Fax

3 28 november 2013 DAY 01 #01 CLINICAL TRIAL DOCUMENTATION 09:30-13:00 1. Investigator s Brochure 2. Clinical Trial Protocol #01 (CONT.) CLINICAL TRIAL DOCUMENTATION 14:30-18:00 3. Case Report Forms Sílvia Sirgado (Lean Data; Blueclinical) 4. Informed consent

4 29 november 2013 DAY 02 #02 DESIGN OF HUMAN PHARMACOLOGY STUDIES 09:00-13:00 1. First-in-Man studies Teresa Nunes, MD, MSc, MBA (PRA Phase I) 2. Biopharmaceutical studies #02 (CONT.) DESIGN OF HUMAN PHARMACOLOGY STUDIES 14:30-18:00 3. Drug-drug interaction studies Teresa Nunes, MD, MSc, MBA (PRA Phase I) 4. Studies on the effect of intrinsic factors Teresa Nunes, MD, MSc, MBA (PRA Phase I)

5 30 november 2013 DAY 03 #03 INTRODUCTION TO PHARMACOKINETICS 10:00-13:00 1. Estimation of pharmacokinetic parameters Amílcar Falcão, PharmD, PhD (University of Coimbra; 4Health Ltd) 2. Statistical approach to pharmacokinetic data Amílcar Falcão, PharmD, PhD (University of Coimbra; 4Health Ltd) 3. PK/PD relationship Amílcar Falcão, PharmD, PhD (University of Coimbra; 4Health Ltd) #04 QUALITY MANAGEMENT IN CLINICAL RESEARCH 14:30-17:30 1. An overview of quality management in clinical research Inês Barbosa, BSc (MSD) 2. Quality control and clinical trial monitoring Inês Barbosa, BSc (MSD) 3. Audits and inspections Inês Barbosa, BSc (MSD)

6 Post-course e-learning workshops e-workshop #01 Prescribing for particular populations e.g. children, elderly, pregnant and breast-feeding women, patients with renal or hepatic impairment e-workshop #03 Ethics in clinical research e-workshop #04 Introduction to data analysis

7 EXPLORATORY & CONFIRMATORY CLINICAL DEVELOPMENT: CLINICAL PHARMACOLOGY This module is a mandatory part of the curricular unit Exploratory and Confirmatory Clinical Development: Clinical Pharmacology. To achieve the curricular unit objectives and learning outcomes the participant should complement module participation with other planned learning modalities, including a variety of written assignments. Curricular unit learning outcomes: On successful completion of this Module the participant should be able to: 1. Describe the early studies in patients: dose-finding/ proof of concept studies and their impact on drug development plan. 2. Outline the design of clinical trials, including legal, regulatory, ethical & practical aspects and Good Clinical Practice (GCP). 3. Discuss the principles and application of statistics in clinical trials. 4. Describe the procedures for clinical trial data collection (paper & electronic) and data management (including validation processes) to ensure optimal quality data. 5. Identify the key strategic and operational issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP). 6. Describe the role of the Investigator Drug Brochure (IDB). 7. Discuss the principles and practical relevance of ethical issues in biomedical research. 8. Outline the legal and ethical provisions for protection of clinical trial subjects Course Project Manager: Carla Rodrigues, BSc ENDORSEMENT EXTERNAL ACCREDITATION

PRODUCT RESEARCH & DEVELOPMENT PROCESS

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