EU clinical trial safety and pharmacovigilance regulations rank among the most demanding compliance frameworks in the world. Under the EU Clinical Trials Regulation (EU No 536/2014) and the Good Pharmacovigilance Practice guidelines, sponsors and trial leaders must navigate more than 27 jurisdictions, 16 GVP guidance modules, and expedited safety reporting timelines that leave virtually no margin for error.
This certified program is designed to give you a commanding understanding of the EU’s clinical trial safety and pharmacovigilance regulatory landscape and to equip you to manage compliance across every stage of the trial lifecycle. You will build deep expertise across a wide range of critical topics, including the EU Clinical Trials Regulation, the Clinical Trials Information System (CTIS), SUSAR reporting obligations, EudraVigilance submission requirements, and Good Pharmacovigilance Practice module compliance. You will also master signal detection and management, Periodic Safety Update Reports, post-authorization safety studies, and the ethical frameworks governing patient safety and informed consent within multi-member-state trials.
Furthermore, this program will arm you with the practical skills to design and implement pharmacovigilance systems that meet EMA standards, manage safety data across complex multi-country trials, and respond decisively to regulatory inspections. You will gain actionable insight into risk-based monitoring strategies, audit trail validation, safety data reconciliation, and the evolving requirements introduced by recent regulatory reforms. By the end of the program, you will be fully prepared to lead pharmacovigilance functions, protect trial integrity, and sustain compliance across the full spectrum of EU regulatory obligations.
Upon successful completion, you will earn the Certified EU Clinical Trial Safety and Pharmacovigilance Manag
er (CTS™), a distinguished credential that validates your mastery of clinical safety governance, pharmacovigilance compliance, and regulatory risk management. With lifelong validity, it elevates your professional standing and positions you as a trusted authority ready to lead proactive safety oversight, decisive risk mitigation, and regulatory excellence across pharmaceutical and clinical research organizations.
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This program will entitle you:
Download Brochure Pricing & Registration- Experience 3 days of live, instructor-led training to master EU clinical trial safety regulations, strengthen safety risk management, and elevate regulatory inspection readiness—equipping you to ensure compliance, make confident safety decisions, and address regulatory challenges decisively.
- Earn the Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™), recognizing your expertise in safety reporting, benefit-risk assessment, sponsor accountability, and inspection-ready pharmacovigilance operations.
- Gain implementation-ready strategies for every critical area of EU clinical trial safety and pharmacovigilance—from adverse event management, expedited safety reporting, and signal detection to benefit-risk assessment, safety governance, and regulatory inspection readiness.
- For inquiries, chat with our Program Advisers at [email protected] 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
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, the body that sets and upholds the governing standards for every professional who completes this program—ensuring your credential carries genuine professional weight.
The content of this program has been fully certified and accredited by the CPD Certification Service as meeting the highest standards of Continuing Professional Development principles. CPD is the leading independent CPD accreditation institution, operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice, and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
Under EU Clinical Trials Regulations, sponsors must report fatal or life-threatening suspected unexpected serious adverse reactions (SUSARs) within seven days of awareness, and all other SUSARs within 15 days. A single misclassified safety event, missed deadline, or lapse in oversight can place participants at risk, invite regulatory intervention, and derail clinical development. These obligations demand accurate assessments, documented decisions, and unambiguous sponsor accountability
This certified program equips you with the expertise to manage EU clinical trial safety, pharmacovigilance compliance, and regulatory reporting in accordance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP). You will learn to assess serious adverse events, identify SUSARs, determine expectedness using Reference Safety Information (RSI), and manage expedited EudraVigilance submissions. The program also covers ICSR management, E2B(R3), MedDRA coding, DSURs, CTIS reporting obligations, urgent safety measures, and serious breach notifications.
Beyond regulatory compliance, you will develop practical capabilities in safety signal detection, risk mitigation, and pharmacovigilance governance. You will strengthen sponsor oversight, manage outsourced safety activities, address emerging safety concerns, and establish effective safety management processes throughout clinical development.
Through practical case studies, you will learn to resolve safety reporting failures, improve data reconciliation, investigate compliance gaps, and implement effective corrective and preventive actions (CAPA). You will also gain the skills to strengthen inspection readiness, reduce recurring errors, improve reporting timeliness, and measure safety performance through meaningful compliance indicators.
Upon successful completion, you will earn the Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™) designation, validating your expertise in clinical safety oversight, pharmacovigilance compliance, and regulatory risk management. This certification elevates your professional credibility and accelerates your advancement into greater responsibilities in clinical safety, drug safety management, and pharmacovigilance leadership.
Key Skills You Will Gain
- EU CTR 536/2014 Regulatory Compliance
- Good Clinical Practice (GCP) Compliance
- Good Pharmacovigilance Practice (GVP) Compliance
- Clinical Trial Safety Governance
- Clinical Trial Sponsor Safety Oversight
- Adverse Event (AE) Assessment
- Serious Adverse Event (SAE) Management
- SUSAR Identification and Reporting
- Expedited Safety Reporting Compliance
- Urgent Safety Measures (USM) Management
- EudraVigilance SUSAR Reporting
- Individual Case Safety Report (ICSR) Management
- E2B(R3) Electronic Safety Reporting
- MedDRA Coding and Terminology
- Safety Data Quality Management
- Reference Safety Information (RSI) Assessment
- DSUR Preparation and CTIS Annual Safety Reporting
- Pharmacovigilance Signal Detection
- Signal Validation and Evaluation
- Benefit-Risk Assessment
- Risk Management Plan (RMP) Development
- Safety Risk Minimization
- QPPV Governance and Oversight
- Pharmacovigilance System Master File (PSMF) Management
- Clinical Safety Data Reconciliation
- CRO and Pharmacovigilance Vendor Oversight
- Pharmacovigilance Quality Management Systems
- Root-Cause Analysis and CAPA Management
- Pharmacovigilance Audit and Inspection Readiness
- CTIS Safety Notifications and Regulatory Compliance
Your Faculty Director
Dr. Irene Michas is a seasoned professional in the field of pharmacovigilance with more than twenty years of experience in the pharmaceutical industry. She served as Regional Safety Manager-Senior Director for the Asia, Africa and Middle East region at Pfizer Research and Development UK where she managed and implemented new business initiatives and updates to procedures and systems. She has led working groups for the development and global implementation of numerous initiatives to facilitate compliance with pharmacovigilance requirements.
Dr. Michas’ expertise also extends to the development of comprehensive training programs to support the global rollout of new pharmacovigilance systems (e.g., Argus, ARISg), and in leveraging advanced technology for the development of e-learning programs. Her in-depth knowledge of international pharmaceutical product regulations and extensive experience in various aspects of drug development activities make her an exceptionally qualified professional in the field of pharmacovigilance.
Dr. Irene Michas is a Phi Beta Kappa scholar with a Bachelor of Arts degree in the field of Biological Basis of Behaviour from the University of Pennsylvania, USA, as well as an MSc and PhD in Psychology (Developmental, Cognitive, Experimental) from Reading University, UK.
Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™) Program Agenda
Chartered Exam
At the end of the program, you will sit a Chartered exam of 50 multiple-choice questions. Pass it, and you will be accredited with the coveted Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™) credential.
- 98% of participants who have sat this exam have passed—nearly every professional who completes our programs goes on to earn their certification.
- The exam consists of 50 multiple-choice questions, and just 25 out of 50 correct answers secure your pass.
- You can retake the exam online as many times as you need, with no additional charge for any retake.
- The exam is already included in your program fee, so sitting it costs you nothing extra.
And should the exam prove challenging, our team and faculty leader stand ready to support you every step of the way to success.
Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™) Designation
Upon successfully completing the program, you will earn the Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™) designation. This distinguished certification validates your professional mastery of EU clinical trial safety requirements, pharmacovigilance risk management, and regulatory compliance—demonstrating your proven ability to deliver effective safety reporting, stronger sponsor oversight, proactive risk mitigation, and inspection-ready clinical safety systems.
This program is developed by the Chartered Institute of Professional Certifications, and its content is certified by the CPD Certification Service as conforming to Continuing Professional Development principles—giving your credential independent, globally recognized standing.
Pricing & Registration
Europe
Dates: 26 - 28 May 2027
Venue: Online Executive Program (via Zoom)
Time: 9:00am - 4:30pm British Summer Time (BST)
10:00am - 5:30pm Central European Summer Time (CEST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 23 Mar 2027 | By 04 May 2027 | After 04 May 2027 | |
| EU Delegates | EUR 1,695 | EUR 1,895 | EUR 1,995 |
| Switzerland Delegates | CHF 1,595 | CHF 1,795 | CHF 1,895 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
Download our program brochure below. For any inquiries about this program, please contact our Program Advisor at [email protected] 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
- Canada: +1 833 879 8820
- USA: +1 888 745 8875
Convincing Your Boss To Attend This Program
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Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™)
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