Continuing Professional Development

The ECPM Continuing Professional Development (CPD) platform provides accredited high quality educational programs to support continuing medical education and professional development for physicians, and pharmaceutical industry, regulatory and university professionals. As such, its primary intention is to provide up-to-date knowledge on current trends in drug development and to train drug development professionals for their next career step. Additionally, it offers a platform to share knowledge with colleagues and discuss with experts face-to-face. Our services include a broad range of CPD short courses that cover all skills across the drug development process. These CPD short courses count towards the Master program, yet they are also a stand-alone offer and can be booked individually to shape your professional skills and are offered in the following formats:

Short Courses/Workshops - A range of interactive onsite short courses/workshops. These cover a broad curriculum within the drug development process - from educational seminars to soft skills.

Frontiers in Drug Development Seminar - One day onsite seminars on new trends in drug development science.

E-Learning -Selected e-learning courses that provide an interactive environment for self-paced learning and can be booked at any time.

Study Trips - Yearly international study trips. A total of six study half-days are planned, which allow participants to experience a mix of theory and visits to institutions.

Courses offered by other Course Providers - Co-organized courses with other institutions, such as the University Hospital of Basel or partner universities. In addition, students also have the opportunity to choose courses offered by PharmaTrain Recognized Course Providers.

If you are interested in receiving information about our courses please subscribe to our ECPM newsletter.

ECPM Clinical Trial
07.12.2021 08:00

DAS Clinical Trial Practice and Management - December 2021 or February 2022 until 2023

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Course Description

Successful clinical research requires clinical experience, but also extensive knowledge about all phases of the clinical research process, awareness of regulatory requirements as well as project management and leadership skills. The complex and highly competitive nature of clinical research, results in a growing need for well-trained clinical research professionals, not least those working as study coordinators, study managers, clinical monitors or clinical research assistants.

Clinical research professionals usually start their careers with background knowledge from diverse graduate training often lacking structured training in clinical research. Still, they are facing highly demanding responsibilities in a complex, ever-evolving, interdisciplinary and often multinational environment. Fortunately, training at the postgraduate level is increasingly being recognized as essential to developing scientific, technical and interpersonal competencies to ultimately enhance the quality of clinical research.

The goal of this program is to prepare trainees for the variety of management and leadership roles in different clinical research settings such as academia, pharmaceutical, medical device or biotech industry, clinical research organizations and regulatory agencies.

Course Organizer and Registration

This course is organized by the CTU Clinical Trial Unit, University Hospital of Basel.
Course details and registration
 

 

10.02.2022 08:30

The Right Dose for Every Patient

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The Right Dose for Every Patient

Characterizing the dose response relationship and subsequent determination of an adequate dose level in humans are key objectives in the development of a medicinal product. Dose finding studies and modeling and simulation techniques play a key role in the transition of a drug from the non-clinical to the clinical phase and represent the gatekeeper for first in human studies and large confirmatory clinical trials.

With the rise of precision medicine comes a promise for greater dose flexibility to further improve efficacy and reduce adverse effects. Some groups in the population require special clinical studies due to specific dosing, pharmacokinetics and administration characteristics. The use of medicines in the elderly requires special consideration due to the frequent occurrence of underlying diseases and the consequent risk of medicines interaction of the various treatment regimens. Gender and sex are important drivers of phenotypic variability in patient populations. Microdosing studies offer the possibility to study the mechanism of action and pharmacodynamics with sub-therapeutic exposure.

The seminar is designed to provide an overview of current concepts in non-clinical and clinical pharmacology and drug dosing with special consideration of the individual patient and the predisposition of special populations. We look forward to welcoming you and your colleagues on 10 February, 2022!

About Frontiers in Drug Development Seminars

ECPM offers one day seminars on current topics, new trends and developments in drug development science. These seminars provide the opportunity to integrate work and further education, to discuss with experts face-to-face and to build an international network. They take place on the fourth day of each of the six modules of the Diploma Course and are mandatory for students taking the Diploma Course. Additionally they are open to our alumni and other interested scientists and can be booked separately.

Learning Outcomes

Participants will learn about the:

  • Future trends in drug development including Future Information Technologies, Nano-Technologies, Computer Simulation and Modelling, Personalised Medicine, Genomics, Biologicals and Biosimilars, Advanced Therapeutics
  • Regulatory Agency updates from FDA, EMA and Swissmedic
  • Ethical, Economic and Epidemiological Considerations and Concepts in Drug Development

Language

English

Program

One-day workshops, recognised for continuing professional development. The workshops are held on day four of each ECPM Course Module.

Credits

Accredited as continuing education by the Swiss Society of Pharmaceutical Medicine (SGPM) and the Swiss Society of Pharmaceutical Professionals (SwAPP)

Fee

Course fee including certificate and electronic course material is CHF 680 and CHF 580 for ECPM Alumni and SwAPP/SGPM members. A reduced fee applies to participants from academia and nonprofit organizations.

Cancellation Policy

Refund of fee will be given if cancellation is received in writing before the deadline for registration, after this date no refund can be given. Speakers are subject to change without notice.

Date and Venue

Thursday, February 10, 2022
Biozentrum, Spitalstrasse 41, 4056 Basel

Deadline for Registration

30 January, 2022

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

Registration
07.11.2022 08:30

Ethical and Legal Aspects of Clinical Trials

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Course Description

The implementation of clinical research projects requires conscientious review of research projects not only in terms of their scientific quality but also in regard to their ethical adequacy and appropriateness. How can we balance the risk-benefit of our projects? Given the importance of ethics for the conduct of drug development and research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.

Each of these aspects will be carefully considered and discussed in the context of international and national principles and guidelines. These issues need to be carefully adhered to strengthen the health of the clinical trial enterprise to the benefit of patients and the overall health of the public. During our course, representatives from different institutions will introduce and discuss the most important concepts, tools, principles, and methods that can be useful in approaching and resolving ethical dilemmas. Realworld examples and case studies will be introduced and discussed.

Course Program

Day 1
The Evolution of Biomedical Research Ethics / Risk-Benefit Considerations of Research Interventions / Role of Ethics Committees / Successful Submission to an Ethics Committee / Coordinating Human Research in Switzerland / How to Design an Informed Consent / Ethical Review Systems in Europe and European Legislation / Ethics Committees’ Role in Reviewing Safety Information

Day 2
Equipoise / Transparency in Clinical Trials / Common Technical Document / Confidentiality and Intellectual Property / Personal Data Protection / Inducement in Clinical Research – from Recruitment Advertisement to Subject Compensation / Role of Patient Organisations in Clinical Trials (EUPATI) / Public Health Ethics (incl. biobanks)

Day 3
Ethical Aspects of Clinical Research in Children / Informed Consent Process in Pediatric Patients / Clinical Research in Vulnerable Populations / Misconduct and Fraud, Research Integrity / ICH E6 Regulation / Legal and Ethical Framework for Genetic Testing

Learning Outcomes

By the end of the course, students will be able to:

  • Name key principles of ethical considerations during clinical research and development
  • Discuss ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical trials
  • Understand international and national principles and guidelines which have to be followed when performing clinical trials

Course Faculty

Dr. Jane Barrett
Dr. Julia Bielicki
Dr. Corina Braem
Dr. Thomas Gruberski
Nienke Jones
Dr. Peter Kleist
Dr. Ingrid Klingmann
Dr. Sabine Österle
Dr. Nicole Probst
Magalie Wasem-Tréguer
Dr. Beat Widler

Target Audience

All pharmaceutical and health care professionals who are interested in getting a deeper understanding of ethical and legal aspects in medicines development.

Course Language

English

Course Credits

The course including assessment provides 2 ECTS credits.

Course Date and Venue

Basel, 7-9 November, 2022.

Course Fee

Course fee including certificate, electronic course material and coffee breaks is CHF 2000.
A reduced fee applies to participants from academia and nonprofit organizations.

Cancellation Policy

Refund of fee will be given if cancellation is received in written format () before the deadline for registration, after this date no refund can be given.

Deadline for Registration

Will be announced for November 2022.

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

ECPM European University Network
ECPM partner universities in the European University Network
01.01.2023 08:10

Other Courses by Pharmatrain

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Join courses run by our partner universities in the European University Network, which offer training relevant to drug development sciences and the IMI PharmaTrain syllabus. For an overview of all PharmaTrain Recognized Course Providers please click here.

E-Learning: Basics in Health Economics

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Course Description

This e-learning course provides an understanding of the key principles and methodological concepts of health economic evaluations. It is based on the well-established face-to-face course on health economics offered by the ECPM. The scientific content was developed by Prof. Thomas Szucs and Prof. Matthias Schwenkglenks as well as other specialists from the field.

Learning Outcomes

At the end of the course, the participants should be able to describe:

  • Fundamental concepts of health economics
  • Key elements of health economic evaluation
  • Assessment and analysis of a published health economic study
  • The importance of health economic/pharmacoeconomic methods and concepts for the drug development process, clinical trials, and post-marketing surveillance
  • How policymakers set priorities in health care and how health economic evaluations support this process

Structure and Workload

Our e-learning courses provide an interactive environment for self-paced learning. As soon as you have booked the course, the program is accessible online for you during one year at anytime. The course allows you to start/stop at any time. There will be several intermediate tests which will prepare you for the final test. The curriculum consists of nine lessons with a duration of approximately 60 to 90 minutes each. In addition, individual study, such as critical appraisal of specific literature is required (in total: approximately 30 hours). Each lesson is aimed to achieve a set of learning outcomes, using interactive techniques to help reinforce the taught topics.

Course Language

English

Course Credits

After successful completion of the e-learning course, 1 ECTS will be awarded (Certificate of Attendance from the University of Basel).

Course Fee

CHF 650
A reduced fee applies to participants from academia and nonprofit organizations.

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

Registration

E-learning: Drug Safety and Pharmacovigilance

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Course Description

This e-learning course provides an understanding of the safety-related aspects within the drug development process. These range from early preclinical testing, risk/benefit assessment up to clinical adverse event signal detection and monitoring.

Learning Outcomes

At the end of the course, the participants should be able to describe:

  • The role of drug safety in the successful development and usage of a medicine to the benefit of patients
  • Which safety-related questions need to be answered in early and late drug development
  • Tools, techniques, and methodologies used in drug safety evaluation
  • What frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launch
  • How changes in safety assessment could become part of a new drug development paradigm

Structure and Workload

Our e-learning courses provide an interactive environment for self-paced learning. As soon as you have booked the course, the program is accessible online for you during one year at anytime. The course allows you to start/stop at any time. There will be several intermediate tests which will prepare you for the final test. The curriculum consists of nine lessons with a duration of approximately 60 to 90 minutes each. In addition, individual study, such as critical appraisal of specific literature is required (in total: approximately 30 hours). Each lesson is aimed to achieve a set of learning outcomes, using interactive techniques to help reinforce the taught topics.

Course Language

English

Course Credits

After successful completion of the e-learning course, 1 ECTS will be awarded (Certificate of Attendance from the University of Basel).

Course Fee

CHF 650
A reduced fee applies to participants from academia and nonprofit organizations.

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

Registration

E-Learning: Personalized Health Care

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Course Description

This e-learning course provides an understanding of the key principles and methodological concepts of personalized drug development. The role of individualized treatment strategies is addressed, including all relevant clinical, ethical and governmental aspects.

Learning Outcomes

At the end of the course, the participants should be able to:

  • Understand the biological and clinical concepts of personalized medicine
  • Understand the benefits and pitfalls of individualized therapies for patients
  • Comprehend the basic elements of predictive and prognostic interventions
  • Understand the role of surrogate endpoints and clinically validated biomarkers in personalized medicine
  • Understand pharmacogenetic and pharmacogenomic implications
  • Be aware of the strategies of R&D processes with personalized drugs
  • Understand the economics challenges of personalized medicine and how policymakers set priorities in individualized health care
  • Determine legal, regulatory and ethical aspects of personalised medicine

Structure and Workload

Our e-learning courses provide an interactive environment for self-paced learning. As soon as you have booked the course, the program is accessible online for you during one year at anytime. The course allows you to start/stop at any time. There will be several intermediate tests which will prepare you for the final test. The curriculum consists of nine lessons with a duration of approximately 60 to 90 minutes each. In addition individual study, such as critical appraisal of specific literature is required (in total: approximately 30 hours). Each lesson is aimed to achieve a set of learning outcomes, using interactive techniques to help reinforce the taught topics.

Course Language

English

Course Credits

After successful completion of the e-learning course, 1 ECTS will be awarded (Certificate of Attendance from the University of Basel).

Course Fee

CHF 650
A reduced fee applies to participants from academia and nonprofit organizations.

Course Organizer

This course is organized by the European Center of Pharmaceutical Medicine.

Registration