Managing clinical trials in the EU is exceptionally complex. Over 60% of cross-border studies encounter delays due to inconsistent implementation across Member States, discrepancies in ethical reviews, and administrative bottlenecks. These hurdles are intensified by the need to engage with multiple regulatory authorities, each applying EU rules differently, and by local ethics committee requirements that can extend approval timelines by weeks or even months. Additionally, inconsistent documentation practices, and divergent contract negotiations that make trial execution even more challenging.
This certified program is designed to empower clinical trial leaders with the essential knowledge, regulatory expertise, and operational strategies needed to successfully manage trials under the EU Clinical Trial Regulatory framework. Covering the entire trial lifecycle, you will gain practical insight into EU Clinical Trials Regulations, Good Clinical Practice (GCP), and multinational trial coordination. Core modules emphasize submissions, ethics approvals, and cross-border delivery, while ensuring patient safety, data integrity, GDPR compliance, and the ethical treatment of vulnerable populations. Advanced topics also cover trial design, patient recruitment, informed consent, centralized monitoring, and documentation, alongside leadership skills to build and lead high-performing teams.
The program further explores specialized areas such as pharmacovigilance, safety monitoring, risk-based quality management, and investigational medicinal product oversight. Participants will master strategies to address the unique complexities of multinational delivery, reinforced through case studies on rare diseases, gene therapies, and AI-driven innovations. The program concludes with advanced training in compliance and quality assurance, including inspection readiness, trial close-out, and data archiving. By completion, you will be fully equipped to lead diverse, high-impact clinical trial teams across Europe.
Upon completing the program and passing the Chartered exam, you will attain the Certified EU Clinical Tri
als Project Manager (CCT™) designation, an internationally recognized credential that demonstrates your ability to deliver compliant, ethical, and efficient clinical trials across the European Union. This certification will not only enhance your credibility and career advancement opportunities but also position you as a trusted leader capable of guiding clinical research organizations through Europe’s complex regulatory environment with confidence and excellence.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Pricing & Registration- Experience 3 days of instructor-led live training designed to build advanced competencies in EU clinical trial management, regulatory compliance, and cross-border trial coordination across Europe's complex healthcare landscape.
- Attain the industry-recognized Certified EU Clinical Trials Project Manager (CCT™), demonstrating your comprehensive expertise in the full clinical trial lifecycle in Europe, from protocol design, budgeting, and CTA submission via CTIS, to trial close-out, archiving, and regulatory reporting.
- Gain practical tools and strategic insights into the latest advancements in MedTech, artificial intelligence, and advanced therapy medicinal products, and develop the expertise to effectively integrate these innovations into clinical trial practices.
- For inquiries, chat with our Program Advisers at advisor@charteredcertifications.com or call us at
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Accreditations
This Certified EU Clinical Trials Project Manager (CCT™) is a mark of excellence and distinction that signifies a fully qualified expert possesses profound expertise in applying EU regulatory frameworks to optimize trial efficiency, ensure patient safety, and maintain compliance across Europe’s complex clinical research landscape. It is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all members. The CCT™ charter is a trademarked charter available only to professionals who have completed and passed this program. The certification is governed and maintained by Chartered Institute of Professional Certifications with over 90,000 members around the world. It is also endorsed by prominent associations and organizations worldwide.
The content of this program has been fully certified and accredited by CPD as adhering to Continuing Professional Principles.
What You Can Expect from This Live Program
Recent data reveals 67% of clinical trials face delays, with regulatory compliance issues accounting for 40% of setbacks, costing €3.2 billion annually in the EU. This striking reality emphasizes the critical importance of expert project management in clinical trials. Advanced knowledge of EU regulatory landscapes, risk management, and stakeholder coordination is vital for project managers to minimize delays, optimize resource allocation, and accelerate the delivery of innovative therapies to European patients.
This certified program will provide you with an intensive, hands-on understanding of EU clinical trials management, tailored specifically for project management professionals navigating Europe's complex regulatory landscape. You will gain in-depth knowledge of the EU Clinical Trial Regulation, CTIS portal operations, GCP standards, and the regulatory transition from Directive 2001/20/EC that has transformed clinical research across European healthcare systems.
The program emphasizes leadership in managing multi-national trials, with focused training on cross-border submissions, ethics committee coordination, and National Competent Authority (NCA) interactions. Core frameworks such as risk-based quality management, pharmacovigilance systems, EudraVigilance reporting, and investigational medicinal product (IMP) supply chain management are used to illustrate how regulatory compliance, safety monitoring, and operational excellence contribute to successful trial delivery. You will also explore patient recruitment strategies, informed consent processes, and GDPR compliance to ensure ethical trial conduct across diverse European populations.
Through realistic trial scenarios and structured case studies, you will build skills in regulatory submission management, inspection readiness, and crisis response protocols. Practical modules include adverse event reporting, Development Safety Update Reports (DSURs), Advanced Therapy Medicinal Products (ATMP) regulatory pathways, MedTech device trials, and AI-driven clinical research applications. Advanced tools such as centralized monitoring systems, quality assurance frameworks, and corrective action planning will further strengthen your capability to manage complex trials while maintaining the highest standards of patient safety and data integrity.
Upon completing the program and passing the Chartered exam, you will attain the Certified EU Clinical Trials Project Manager (CCT™) designation. This credential will demonstrate your advanced expertise in integrating EU regulatory frameworks into clinical trial management, driving excellence in research delivery and significantly accelerating patient access to innovative therapies across European healthcare settings.
Key Skills You Will Gain
- EU Clinical Trial Regulation (CTR) Compliance
- CTIS Portal Navigation
- Clinical Trial Application (CTA) Preparation
- Ethics Committee Submissions
- EMA & NCA Coordination
- Safety Reporting and Pharmacovigilance
- Clinical Trial Management System (CTMS)
- Good Clinical Practice (GCP) Standards
- Trial Protocol Development
- Patient Recruitment & Retention Strategies
- Patient Participation
- Informed Consent Processes
- Vulnerable Population Safeguards
- GDPR & Data Confidentiality
- MedTech Device Trials and Artificial Intelligence
- Pharmacovigilance Systems
- EudraVigilance Reporting
- Adverse Event (AE) Management
- Development Safety Update Reports (DSURs)
- Investigational Medicinal Product (IMP) Management
- ATMP Regulatory Pathways
- Supply Chain & Traceability
- Budgeting & Contract Negotiation
- Cross-Border Trial Coordination
- Audit & CAPA Planning
- Trial Close-Out & Archiving
- Risk-Based Quality Management
- Multi-National Trial Coordination
- Centralized & On-Site Monitoring
- Clinical Data Integrity
Your Faculty Director
Professor Sandip Mitra is a distinguished expert with over 20 years of experience in clinical research and EU regulatory affairs. He is a leading authority committed to advancing the fields of clinical trials project management and European pharmaceutical development through innovative research, education, and strategic industry collaboration. Throughout his career, Professor Mitra has held several prominent leadership roles, including UK National Lead for Research Delivery (NIHR), Principal Investigator, and Expert Consultant, across academia, healthcare, and global pharmaceutical organizations.
As a renowned clinical trials leader, Professor Mitra has successfully managed large portfolios of Phase 1-4 trials, supervising postgraduate researchers and securing significant industry partnerships with AstraZeneca, GSK, Novartis, and Baxter. His expertise has empowered countless project managers and healthcare professionals in EU regulatory compliance, multi-national trial coordination, and advanced therapeutic medicinal product development.
Recognized for his exceptional contributions to clinical research excellence, Professor Mitra has received multiple national awards and maintains consistent 9/10 teaching ratings across prestigious UK universities including UCL, Oxford, Manchester, and Sheffield. He is a highly regarded Key Opinion Leader, NIHR Ambassador, and expert reviewer, with specialized certifications and memberships in prestigious research organizations, further cementing his status as a trusted authority in EU clinical trials management.
Certified EU Clinical Trials Project Manager (CCT™) Program Agenda
Chartered Exam
At the end of the program, there will be a Chartered exam comprised of 50 multiple choice questions. Upon passing the exam, you will be accredited with Certified EU Clinical Trials Project Manager (CCT™) designation.
- 98% of students who have taken this exam have passed the exam successfully. Almost all professionals who have taken our courses have passed this test and attain their Certified EU Clinical Trials Project Manager (CCT™) designation
- The exam has 50 multiple choice questions, and you need to answer 25 out of 50 questions correctly to pass exam
- You can re-take the exam online as many times as you want, with no additional charges for retaking of exams
- The program cost already includes the exam fees, so there are no additional charges for taking exam
If you have challenges passing the exam, you can secure assistance from our team and faculty leader to help you pass the exam.
Certified EU Clinical Trials Project Manager (CCT™) Designation
Upon completion of the program and successfully passing the Chartered exam, you will be awarded the prestigious Certified EU Clinical Trials Project Manager (CCT™) designation, which can be showcased in your resume, CV, and other professional credentials. Developed by the esteemed Chartered Institute of Professional Certifications, positions you as a leader in managing complex, multinational clinical trials within the European regulatory landscape. It demonstrates your mastery of the EU Clinical Trials Regulation, patient safety, risk mitigation, regulatory compliance, and best practices essential to driving trial quality and ethical standards. This certification will enhance your credentials, showcase your leadership in clinical trial project management, and empower you to advance innovative therapies efficiently and compliantly across Europe.
The program's content has been independently accredited and certified by the Continuing Professional Development (CPD) organization, guaranteeing adherence to rigorous standards of professional development.
Pricing & Registration
Europe
Dates: 25 - 27 Feb 2026
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm Greenwich Mean Time (GMT) |10:00am - 5:30pm Central European Time (CET)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 15 Dec 2025 | By 26 Jan 2026 | After 26 Jan 2026 | |
| EU Delegates | EUR 1,695 | EUR 1,895 | EUR 1,995 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!
Certified EU Clinical Trials Project Manager (CCT™)
4.6 (330 ratings)