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

tba

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 and a Certificate of Attendance by the University of Basel will be issued.

Course Date and Venue

Basel, 4–6 November, 2024
University of Basel

Course Fee

Course fee including certificate, electronic course material, lunch 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 (ecpm@unibas.ch) before the deadline for registration, after this date no refund can be given.

Deadline for Registration
October 11, 2024

Course Organizer

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

Course Description

This course, offered in two parts of three days each, focuses on projects in the life sciences industry and the clinical trial setting, with the aim of bringing new treatments to patients successfully.

These projects can range from early pre-clinical projects, to managing toxicology and entry into human studies, large phase III clinical trials and post-marketing studies. All of them share a high complexity and require professional management at every level by experienced project managers who know the processes to reach the deliverables, can deal with multiple stakeholders simultaneously and deliver projects successfully often under a tight given budget and timelines.

This highly interactive workshop setting includes a mixture of instructor led training and group work on real life cases. All templates and tools for planning, executing, managing & controlling as well as closing a project will be developed. In addition participants have the opportunity to discuss and work on an own project, identify its challenges and develop solutions or work on a model project provided by the course instructors.

Course Program

This course consists of two parts of three days each. A variety of teaching methods including lectures, exercises and interactive group discussions will be applied. A mandatory home assignment will complete the learning portfolio.

The course covers the following topics:

• Discussion of all project phases (initiation, planning, execution, monitoring & controlling, closure) and knowledge areas
• Management of scope, time, cost, quality, team, communication, risk, procurement and stakeholders
• Development of a project plan, starting from a project charter
• Creation of documents and worksheets for managing clinical trials or other projects relating to pharmaceutical development
• Discussion of Key Performance Indicators (KPIs) for project status
• Discussion of Corrective Action Preventive Action (CAPAs) to prevent the project from getting off track

Learning Outcomes

At the end of the course, participants will

• To develop leadership skills for project management and for building high performance project teams'
• Understand the tasks and responsibilities of a project manager
• Know the major project documents required for conducting projects successfully
• Be acquainted with the tools to manage all knowledge areas throughout all project phases
• Build, lead and manage effective project teams
• Be familiar with the interactions needed with different project stakeholders
• Have a series of templates and tools at hand
• Be able to use and/or adapt these templates and tools within individual projects
• Know how to practically apply different project management standards to all kinds of pharmaceutical development projects

Course Instructors

Daniel Gau is an experienced project management professional in the life sciences sector. He is the founder of Beyond Science Consulting, where he provides training, coaching, and support for company building in life sciences. Daniel has held significant roles in product development and management at companies like Eisbach Bio and 2 Bridge. He has over 20 years of experience in academia, venture capital, start-ups and large corporations. His extensive background includes translating innovation towards relevant business inflection points, making him a valuable instructor for project management in the life sciences industry.

Nancy Van Osselaer is an experienced consultant in life sciences and healthcare, with over 25 years in drug development. She founded Why2What, a consultancy focusing on strategic advice and implementation for early-stage development programs. Nancy has held significant roles at Galapagos, UCB, and Johnson & Johnson, contributing to drug registration files and development programs across various therapeutic areas. Her expertise includes pre-clinical studies, investigational new drug applications,
management, fundraising, and negotiation. She is passionate about turning innovative ideas into impactful, valuable outcomes.

Target Audience

Specialists responsible for projects in the pharmaceutical industry, hospital or academic setting or regulatory authority. The course not only provides the tools and fundamentals for successful project management but also illustrates real life cases. Experienced managers are encouraged to bring their current issues so that solutions can be compiled during the course.

Course Language

English

Course Credits

The course including assessment provides 4 ECTS and a Certificate of Attendance by the University of Basel will be issued.

Course Date and Venue

• Part I: 24-26.03.25
• Part II: 28-30.04.25
  Basel

Course Fee

Course fee including electronic course material, templates, lunch and coffee breaks is CHF 3000.
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 (ecpm@unibas.ch) before the deadline for registration, after this date no refund can be given.

Deadline for Registration

Deadline for registration: 3^rd of March 2025,

Course Organizer

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

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 and a Certificate of Attendance by the University of Basel will be issued.

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.

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 and a Certificate of Attendance by the University of Basel will be issued.

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.

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 and a Certificate of Attendance by the University of Basel will be issued.

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.

Course Description

The program provides a broad overview of the current standard drug development process and offers insights into future trends
Topics:

• Global Drug R&D and the Pharmaceutical Business Environment
• The Life Cycle of a Drug: from Bench to Bedside
• Regulatory Strategy and Approval Process

Content

Module 1: Global Drug Research & Development and the Pharmaceutical Business Environment
Key topics:

• Principles and organisation of global pharmaceutical research and development
• Pharmaceutical business environment: innovation in discovery and development as a response of the market needs
• Trends in the pharmaceutical and biotech industry
• Intellectual property and patenting
• Innovative tools: artificial intelligence, big data, precision medicine

Module 2: The Life Cycle of a Drug: Taking a Molecule into Humans
Key topics:

•  Life Cycle Management
•  Building and selecting a successful drug candidate
• Translational science: from animal to human
• Safety and efficacy testing
• Impact of genomic disposition
• Target Product Profile

Module 3: Global Registration and Market Access
Key topics:

• Regulatory processes and practices around the world
• Most important regulatory authorities: FDA, EMA, PMDA etc.
• Pharmacovigilance: reporting and surveillance system
• Market access: pricing and re-imbursement
• Medical Products Regulatory Processes and practices in the different regions of the world
   

Course Language

English

Course Credits

You can earn 1 ECTS point with this free e-learning by submitting a homework assignment.

Course Fee

Free

Course Organizer

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

Create an account to begin this e-learning course: https://learn.ecpm.ch/login/signup.php

The Vital Role of Patients in Shaping Drug Development 

The involvement of patients in shaping drug development offers invaluable first-hand information on their treatments.

Incorporating patient input into the design and the selection of endpoints in clinical trials ensures that studies address aspects that impact their quality of life, which can lead to higher enrolment rates. Patient-Reported Outcomes (PROs) should be designed to capture the impact of a disease and its treatment from the patient’s perspective.

After a drug is approved, patients continue to play a crucial role through post-market surveillance. Their feedback on the drug's effectiveness, side effects, and impact on daily life helps in identifying long-term benefits and risks. Regulatory agencies are increasingly engaging with patients to understand their perspectives on risk-benefit analyses and regulatory decisions. Patients participate in advisory committees, public hearings and consultations, ensuring that their voices are considered in the regulatory process.

The trend towards patient-centric drug development is not only improving the quality of life for patients but also fostering innovation and efficiency in the healthcare industry. Several initiatives to train patients to provide their input will be introduced.

We are looking forward to welcoming you to meet our distinguished faculty and to discuss these advancements with colleagues.

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 should learn more about various topic such as:

• Gain an understanding of the multifaceted and invaluable role of patients in shaping drug development
• Learn strategies for incorporating patients perspectives for pharmaceutical companies, researchers, and regulatory bodies to develop more effective, safer, and patient-friendly treatments
• Explore real examples illustrating how patient-centric drug development is not only improving the quality of life for patients but also fostering innovation and efficiency in the healthcare industry.

Language

English

Program

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

Speakers are subject to change without notice.

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 580 for ECPM Alumni and CHF 480 for SwAPP/SGPM members. A reduced fee of CHF 210 applies to participants from academia and nonprofit organizations.

After registration you will receive an invoice. For registrations submitted after August 25, the fee must be paid onsite by credit card before the seminar.

Cancellation Policy

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

Deadline for Registration

TBA

Course Organizer

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

Course Description

This course provides continuing professional development at the cutting-edge of medical innovation. It delves into the intersections of genomics, pharmaceutical science and legal considerations, offering a comprehensive understanding of how genomics is reshaping the landscape of pharmaceutical research and development. Through engaging lectures and cases, participants will be exposed to the synergistic relationship between genomics and drug development, as well as delving into the intricate web of ethical considerations surrounding patient consent, data privacy, and equitable access to genomic information.

Course Program

Day 1
Basics of Genetics / Genetic Testing Networks / Genetic Epidemiology and Public Health Genetics / Using Genetics and Genomics for Target Identification and Drug Discovery

Day 2
Using Genetics and Genomics in Clinical Development / Treatment of Genetic Diseases incl. Gene-Therapy / Genetics and Genomics in Drug Safety Evaluation / Ethical, Legal and Social Aspects incl. Data Protection Aspects

Learning Outcomes

Upon completion of this course, participants will be able to: :

• Understand the crucial principles of genomics and its direct relevance to the drug development process.
• Acquire insights into the intricate process of translating cutting-edge genomics research into actionable strategies for drug discovery.
• Navigate the intricate web of ethical dilemmas and multifaceted regulatory considerations that emerge from the integration of genomics in medical research and therapeutics.
• Analyse the intricate legal frameworks underpinning genomics in drug development and the dynamic interplay between scientific progress and legal intricacies.
• Cultivate a globally informed perspective on the challenges, opportunities, and future trajectories of genomics within the pharmaceutical landscape.

Course Faculty

The faculty boasts international experts from multiple disciplines relating to genomic medicine:

• Prof Sabine Gallati Kraemer, co-lead Genomic Medicine, Hirslanden Clinic, Zurich
• Prof. Thomas Szucs, co-lead Genomic Medicine Hirslanden, Zurich and ECPM, University of Basel
• Prof Nicole Probst, Head of the Department of Epidemiology and Public Health and the Chronic Disease Epidemiology Unit at Swiss TPH, Basel
• Prof Vincent Moser, Canada Excellence Research Chair in Genomic Medicine, Montreal
• Prof Claudia Seitz, attorney and lecturer in Public Law, European Law, International Law and Life Sciences-Law

Target Audience

This course is tailored for a wide range of participants including: researchers in genomics and pharmaceuticals, healthcare professionals seeking to understand the integration of genomics into personalised medicine, legal professionals interested in the interface of genomics and life science law, industry leaders looking to stay informed about personalised healthcare and ethicists interested in the responsible implementation of genomic medicine.

Course Language

English

Course Credits and Certificate

Participation and submission of assignment result in a Certificate of Attendance by the University of Basel with 1 ECTS credit point and is also accredited with 100 FPH-points in hospital pharmacy and 100 FPH-points in clinical pharmacy by the Swiss Society FPH Spital (Fachgesellschaft FPH Spital).

Course Fee

Course fee including certificate, electronic course material, lunch and coffee breaks is CHF 1950.
The reduced for participants from academia and nonprofit organizations is CHF 950.

Cancellation Policy

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

Course Organizer

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

Course Description

This course intends to provide the participants with an understanding of the key principles and methodological concepts of health economics. The role of health-economic thinking in the drug development process is addressed. Two group exercises will complement lectures and discussions.

Course Program

The program includes theoretical background sessions and is enriched with exercises and in-group exercises

• Basic economic concept and principles
• Health economic evaluations principles and methods
• Health economic evaluation in drug development
• Health technology assessments and reimbursement
• Health economic evaluation alongside clinical trials and the need for modelling
• Budget impact analysis – relevance, principles, and relationship with cost-effectiveness analysis

Learning Outcomes

At the end of the course, the participants will

• Understand the fundamental concepts of health economics.
• Understand key principles of health economic evaluation.
• Be able to assess and appraise a published health economic analysis according to guidelines and checklists.
• Understand the importance of health economic/pharmacoeconomic methods and concepts for the drug development process, clinical trials, and post-marketing surveillance.
• Understand how policymakers set priorities in health care and how health economic evaluations support this process
• Understand the importance of health technology assessment in different health care systems.
• Understand rational choice and priority setting using economic evaluation.

Course Faculty

Prof. Thomas D. Szucs, MD MPH MBA LLM
Michaela Barbier, PhD 
Arjun Bhadhuri, PhD
Sandro Stoffel, PhD
Judith Lupatsch, PhD
Jana Bartakova, PhD

Speakers from Pharmaceutical Industry

Target Audience

All pharmaceutical and health care professionals who are interested in getting a fundamental understanding of health economics and health economic evaluations in the context of drug development.

Course Language

English

Course Credits

The course including assessment provides 2 ECTS credits.

Course Fee

Course fee including electronic course material, coffee breaks, lunch and certificate is CHF 1800.

A reduced fee applies to participants from academia and nonprofit organizations. Please contact ecpm@unibas.ch.

Cancellation Policy

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

Course Organizer

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

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.