Universität Basel

Faculty of
Medicine

Department

ECPM Course

Course Structure

The ECPM course program consists of 24 face to face teaching days divided into six modules over a period of two years (4 days from Monday to Thursday, eight hours per day, each lesson 45–75 minutes), including team involvement in mentored, case-oriented breakout sessions. In addition, approximately eight hours of distance learning per module is required in order to prepare for the case studies. The course language is English.

To register for the ECPM course, please scroll down to the end of the page, where you will find the registration buttons.

Two Parts form the ECPM Course

  • ECPM Course Modules - The focus of the ECPM Course Modules is on teaching the basics of drug development. Upon completion of the six modules, students can choose to either take a multiple choice questions (MCQ) exam, resulting in a CAS in Pharmaceutical Medicine. In order to qualify for a DAS in Pharmaceutical Medicine, students will need to take the MCQ exam, as well as an oral and an essay exam.

  • Continuing Education Seminars – ‘Frontiers in Drug Development’ - While the first three days of each module focus on teaching the basics of drug development, the fourth day is conducted as a seminar, dedicated to new trends and developments in drug development science. It is possible to book the ‘Frontiers in Drug Development’ seminar separately, as continuing professional education. The seminar is open to our alumni and other interested professionals. For participants of the ECPM course, the seminars are mandatory.

The six ECPM Course Modules in detail:

Global Drug Development and Pharmaceutical Business Environment

Principles and organization of global pharmaceutical research and label-driven product development. Future directions of global pharmaceutical and health economics and business environments, and implications for drug selection, drug development, regulatory and business evaluations.
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Description

Principles and organization of global pharmaceutical research and label driven product development. Future directions of global pharmaceutical, health economics and business environments, and implications for drug selection, drug development, regulatory and business evaluations. Innovation in discovery and development as a response to medical and market needs. Health economics and disease management and their application in the changing healthcare environment. Patenting of new chemical and biological compounds.

Key Topics

  • Discovering, modifying, assessing and patenting new chemical and biological compounds
  • System biology and principles of translational research
  • Target identification and validation
  • Introduction in the drug development process and the healthcare environment
  • Drug development for special populations
  • Project and portfolio management techniques

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. Principal discovery and validation steps in drug development
  2. The elements, functions and the management involved in the translational research and integrated development of a new drug
  3. Principles of patenting new chemical and biological compounds

From Non-Clinical Testing to First-in-Humans

Prioritizing areas of therapeutic interest and target product profile. Principles for target identification, understanding of combinatorial chemistry and drugability of new compounds. Exploring possible new drugs by means of preclinical safety and efficacy testing.
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Description

Prioritizing areas of therapeutic interest and target product profile. Principles for target identification, understanding of combinatorial chemistry and drugability of new compounds. Exploring possible new drugs by means of preclinical safety and efficacy testing. The choice and the predictive value of animal testing for toxicity data as well as the principles of ADME, possibilities and opportunities of computer assisted modelling on the way to proof of concept. Procedures and databases for pharmacovigilance and pharmacoepidemiology surveillance. Pharmaceutical engineering and choice of formulation.

Key Topics

  • Non-clinical testing for chemical and biological compounds, including pharmacology (ADME) and toxicology
  • Development, testing and formulation of chemical and biological compounds
  • Non-clinical testing requirements prior to First-in-Human studies
  • Molecular and cellular basis of toxicological reactions
  • Genetic and genomic factors in drug development and drug response
  • Transition from non-clinical to First-in-Human studies
  • Clinical pharmacology and application to clinical development

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. Value of non-clinical testing programs and their integration into the overall drug development plan
  2. Steps in the pharmaceutical development of a drug substance
  3. Principles of clinical pharmacology and their application to clinical development
  4. Requirements, planning and regulations of non-clinical and First-in-Human studies

 

Planning, Collecting and Managing Clinical Data

The planning, the choice of different trial designs, the randomization modes and the choice of endpoints are discussed. The different aspects of the conduct of a trial, principles of Good Clinical Practice, and data management are demonstrated and a basic introduction to biostatistics is given.
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The planning, the choice of different trial designs, the randomization modes and the choice of endpoints are discussed. The different aspects of the conduct of a trial, i.e. study monitoring, principles of Good Clinical Practice (GCP), adverse event monitoring (risk/benefit assessment) and data management are demonstrated. A basic introduction to biostatistics is given.

Key Topics

  • Early studies in patients: dose-finding / proof of mechanism studies
  • Confirmatory clinical development plan
  • Different types of clinical studies, including placebo controlled studies
  • Planning and managing clinical trials
  • Planning of clinical trial supplies for test substance and comparators
  • Legislative requirements and Good Clinical Practice (GCP) in the clinical trial process
  • Investigator and site recruitment, investigative site management and conflict resolution
  • Statistical considerations in the design of clinical trial protocols and analysis of clinical trial data
  • Procedures for clinical trial data collection and data management

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. Management of early studies in patients and their impact on the drug development plan
  2. Design of various types of clinical studies and statistical methods used
  3. The confirmatory clinical development plan including the role of relevant study committees
  4. Key issues involved in the conduct of a clinical study in terms of Good Clinical Practice (GCP)

Clinical and Safety Data Evaluation and Biostatistics

The different tests and methods of biostatistics are discussed. The application of different trial designs is simulated, within-trial decisions, data management, extraction, manipulation and storage of data.
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Description

The different tests and methods of biostatistics are discussed. The application of different trial designs is simulated, within-trial decisions, data management, extraction, manipulation and storage of data.

Key Topics

  • Development of a clinical trial protocol and the investigator drug brochure (IDB)
  • Quality management issues in clinical trials
  • Legal and ethical provisions for protection of clinical trial subjects
  • Statistical methods used in clinical research
  • Collection and evaluation of adverse event data in clinical trials
  • Drug safety monitoring board and other relevant study committees
  • Evaluation and interpretation of clinical trial results

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. Development of a clinical trial protocol and the role of the investigator drug brochure (IDB)
  2. Principles and practical relevance of ethical and legal issues in biomedical research
  3. Evaluation and interpretation of clinical trial results
  4. Main statistical methods used in clinical data evaluation
  5. Collection and evaluation of adverse event data in clinical trials

 

Global Registration and Approval Process

Overview of mechanisms and regulatory management systems in Europe, USA and Asia. Requirements of a regulatory application, documentation and collaboration between developers and regulators. Special regulatory procedures, strategies and crisis management.
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Description

Overview of mechanisms and regulatory management systems in Europe, USA and Asia. Requirements of a regulatory application, documentation and collaboration between developers and regulators. Special regulatory procedures, strategies and crisis management.

Key Topics

  • Regulation of pre- and post-approval of medicines at EU and global level
  • Regulatory activities within a pharmaceutical company
  • Labelling requirements
  • National and international bodies responsible for medicines regulation and their procedures
  • Appeal and Referral
  • Off-label / unlicensed use of medicines
  • International Council for Harmonisation (ICH)
  • Common technical document (CTD)
  • Special Interest Area Community (SIAC)
  • Pharmacovigilance: Classification of adverse events / reactions
  • Safety reporting requirements pre- and post-approval
  • Benefit / risk assessment and pharmacoepidemiology throughout the lifecycle of a medicine

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. General principles of medicines and medical devices regulation (both pre- and post-approval)
  2. Principles and management of drug safety and pharmacovigilance
  3. Role of pharmacoepidemiology in the lifecycle management of a medicine

Integrated Product Development, Healthcare Marketplace and Marketing

Principles of project and portfolio management. Management structure and organization of clinical development. Team work and performance assessment. Interaction between project teams and business. How to place a new drug successfully into the market.
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Description

Principles of project and portfolio management, including aspects of planning, project evaluation and decision making. Management structure and organization of clinical development. Team work and performance assessment. Interaction between project teams and business. How to place a new drug successfully into the market.

Key Topics

  • Principles and regulations of drug marketing
  • Good Promotional Practice: ethical and legal principles pertaining to marketing activities
  • Health economics and health technology assessment (HTA)
  • Patient organizations
  • Life cycle management
  • Strategic considerations for portfolio management

Learning Outcomes

At the end of this module the student should be able to outline the:

  1. Principles and practice of the quality system of drug lifecycle activities
  2. Ethical and legal principles of market introduction of a drug
  3. Principles and practical application of health economics and health technology assessment (HTA) within the healthcare market place

 

 

Registration for the Certificate of Advanced Studies (CAS)

To achieve a Certificate of Advanced Studies (CAS) in Pharmaceutical Medicine by the University of Basel (20 ECTS), it is required to successfully complete a two-year course cycle and to pass the multiple choice questions (MCQ) exam. Please click on the button where you will find the registration buttons to register for the ECPM course and for the MCQ exam.

» » Go to the Registration for the Certificate of Advanced Studies (CAS)

 

 

Registration for the Diploma of Advanced Studies (DAS)

To achieve a Diploma of Advanced Studies (DAS) in Pharmaceutical Medicine by the University of Basel (30 ECTS), it is required to successfully complete a two-year course cycle and to pass the multiple choice questions (MCQ) exam, as well as an oral and an essay exam. The oral examination is based on the pre-reading of a peer reviewed paper. The essay includes three one page summaries on given topics. Participants who apply for the DAS will be registered as students at the University of Basel. Please click on the button where you will find the registration buttons to register for the ECPM course and for the MCQ, oral and essay exams.

Swiss Specialist in Pharmaceutical Medicine (FMH)

For participants, who successfully completed a DAS, can apply as an MD for a Swiss Specialist in Pharmaceutical Medicine offered by FMH (Swiss Association of Medical Doctors) and as an MSc or PhD for a SwAPP (Swiss Association of Pharmaceutical Professionals) Diploma. For more information please consult www.swapp.ch. Please click on the button where you will find the registration buttons to register for the ECPM course and for the MCQ, oral and essay exams.

»» Go to the Registration for the Diploma of Advanced Studies (DAS) and the Swiss Specialist in Pharmaceutical Medicine (FMH)