Small clinical trials, big opportunities
In the realm of drug development, small clinical trial populations hold immense promise despite their size. These trials present unique opportunities for innovation and significant discoveries that ultimately improve patient outcomes. We aim to cover a comprehensive agenda tailored to address the specific needs and complexities inherent in conducting small-scale clinical trials, with several examples in the context of rare diseases. Topics to be discussed include the design of such trials, regulatory considerations, patient engagement and recruitment strategies, data collection and analysis methodologies, as well as case studies and success stories.

Small clinical trial populations are often linked with limited patient populations, necessitating collaboration with patient advocacy groups and healthcare providers to identify suitable individuals. Ethical oversight and regulatory compliance are essential components of conducting small clinical trials for rare diseases. Drug developers must engage in transparent and collaborative relationships with regulatory bodies to navigate the complex regulatory landscape effectively. Certainly, statistical power is another crucial consideration in the design and execution of small clinical trials. By addressing statistical considerations, we aim to equip attendees with knowledge and tools necessary to design and interpret studies effectively.

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 unique opportunities and potential discoveries associated with small clinical trial populations.
• Learn strategies for addressing the specific needs and complexities inherent in conducting small clinical trials, including design considerations and regulatory compliance.
• Explore real examples illustrating successful approaches to designing, executing and interpreting small clinical trials, with a focus on improving patient outcomes and advancing therapeutic innovation.

Language
English

Program
One-day workshops, recognised 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 short notice registration, attendance can only be guaranteed if the seminar fee is paid onsite by credit card.

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.

Date and Venue
Thursday, June 27, 2024

University of Basel, Biozentrum, Spitalstrasse 41, 4056 Basel, Switzerland

Deadline for Registration
June 17, 2024.

Course Organizer
This course is organized by the European Center of Pharmaceutical Medicine

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.

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.

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