EU’s clinical trial regulations are complex - the process for obtaining Clinical Trial Authorization in the EU involves approval from member state authorities, ethics committees, and the European Medicines Agency. In addition, the EU places a high emphasis on patient safety and ethical considerations. Statistics show that over 90% clinical trial applications undergo extensive scrutiny for safety and ethical compliance, leading to delays and modifications in trial protocols.
This certified program is designed to provide you with an in-depth understanding of these complex regulations and help you navigate the challenges throughout the clinical trial process. You will gain expertise on a wide array of critical topics, including the EU Clinical Trial Regulation, Good Clinical Practice (GCP) Compliance guidelines, clinical trials authorization process, subject protection and informed consent. You will also gain insights into the intricate requirements for pharmacovigilance and safety reporting protocols, transparency, and post-marketing surveillance, as well as the impacts of technological advancements on clinical trials in the EU.
Furthermore, this program will equip you with practical skills to integrate these regulations into clinical trial design and management, ensuring compliance and ethical conduct throughout the trial process. This includes understanding the complexities of multi-country trials within the EU and adapting to evolving regulatory requirements. Additionally, you will also gain insights into effective data management techniques and audit trail validation methods using computerized systems. By the end of the program, you will be adept in navigating the complexities of EU clinical trial regulations, equipped with the strategies you need to mitigate risk and ensure compliance.
Upon successful completion of the program, you will attain the Certification in EU Clinical Trial Regulations and Compliance. This distinguished certification will enhance your professional qualifications, demonstrating your proficiency in navigating the legal, ethical, and operational intricacies associated with the conduct of clinical trials. Globally demanded and recognized, the certification holds lifelong validity and will underscore your expertise and amplify your professional credentials in the vital area of clinical trial regulations.
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:
Download Brochure Pricing & Registration- Experience 2 days of instructor-led live program and in-depth understanding of the EU legislation and regulations governing clinical trial practice, along with comprehensive strategies for risk mitigation and compliance.
- Attain the industry-recognized Certification in EU Clinical Trial Regulations and Compliance. This certification will offer a testament to your expertise in conducting legally compliant clinical trials ensuring patient safety and confidentiality.
- Gain insights from impactful case studies and best practices to effectively manage legal obligations, and implement efficient risk mitigation and compliance frameworks.
- 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
- USA: +1 888 745 8875
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional 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
EU’s clinical trials regulation constitutes a complex and comprehensive framework with over 500 pages of rigorous regulations. The regulations also require detailed reporting and transparency, necessitating extensive documentation. Furthermore, the regulation imposes substantial penalties, exceeding €20 million for each instance of non-compliance.
This certified program is designed to empower you with an in-depth understanding of clinical trials management, enabling you to effectively navigate the intricate legal and ethical terrains associated with clinical trials. You will delve into the EU’s legislative framework, clinical trial regulations and its key compliance policies. It will also cover vital regulatory elements including Good Clinical Practice (GCP) Compliance guidelines, clinical trials authorization process, subject protection and informed consent. Moreover, you will gain insights into the clinical trial design and key documentation process, enabling you to draft required content for the trial protocol and create investigators brochures and necessary checklists helping you to maintain subject rights and confidentiality.
Throughout the program, you will also gain expertise into pharmacovigilance and safety reporting protocols which will help you to categorize adverse event types and assist in correct reporting of all safety information. This program will also provide insights into the application of good manufacturing practice to clinical trials and the requirements for Investigational Medicinal Products (IMPs) and Auxiliary Medicinal Products (AxMPs). You will learn effective data management techniques and audit trail validation methods using computerized systems. By the end of the program, you will demonstrate the required expertise to navigate the complexities of EU clinical trial regulations and be equipped with the strategies to mitigate risk and ensure compliance.
Upon successfully completing the program, you will attain the highly respected Certification in EU Clinical Trial Regulations and Compliance, enhancing your professional credentials and amplifying your expertise in the vital area of clinical trials regulations. This industry-recognized certification offers lifelong validity and distinguishes you as an expert in managing ethically and legally compliant clinical trials.
Key Skills You Will Gain
- EU Clinical Regulatory Compliance
- Clinical Trials Regulation
- Good Clinical Practice
- Clinical Trial Applications
- Informed Consent
- Clinical Trials Administration
- Pharmacovigilance
- Risk Assessment
- Ethical Research
- GDPR Compliance
- Clinical Trial Auditing
- Clinical Trial Design
- Clinical Investigations
- Safety Reporting
- Clinical Trial Insurance
- Clinical Quality Assurance (CQA)
- Clinical Trial Reporting
- EU Clinical Trials Legislation
- Clinical Trials Authorization
- Clinical Data Management
- Clinical Trial Documentation
- Investigational Medicinal Products (IMP)
- Auxiliary Medicinal Products (AxMPs)
- Data Integrity
- GCP Inspection
Your Faculty Director
Jo Burmester is an accomplished CEO and clinical research training consultant who has been an industry leader since 1987, renowned for her expertise in Good Clinical Practice (GCP) and ability to engagingly present complex topics. Her distinguished career began as a clinical research associate, then progressed through managerial roles at global pharmaceutical and CRO organizations including Glaxo, Lederle, Wellcome, ClinTrials Research, and Quintiles. This diverse experience imparted broad perspective and specialty in training, which Ms. Burmester has focused on since 1992.
As Co-Founder and former Director of the specialist training company PharmaSchool, she spent 14 years collaborating with various institutions and medical entities to deliver impactful GCP and professional development programs. Since 2018, Ms. Burmester has continued her influential training work as an independent consultant. She holds trainer certification from the Chartered Institute of Personnel and Development and formerly served as Module Leader at Liverpool John Moore’s University. Ms. Burmester has contributed to international clinical research forums, edited the online journal MedSquare, and authored a book on continuing professional development. With renown for her dynamic presentation style, she remains a foremost expert in regulatory and compliance training, covering ICH GCP, clinical research legislation, trial monitoring, and GMP for investigational medicinal products.
EU Clinical Trial Regulations and Compliance Program Agenda
How You Will Benefit
- Explore EU Clinical Trial Regulations: Gain insights into the history, current status, and key objectives of EU Clinical Trial Regulations, understanding the distinction between Directives and Legislation.
- Navigate the Clinical Trials Authorization Process: Understand the Clinical Trials Authorization process, including ethics reviews and modifications, essential for initiating clinical trials in the EU.
- Ensure Participant Protection: Delve into subject protection and informed consent, focusing on participant engagement and maintaining confidentiality and rights.
- Design Effective Clinical Trials: Learn to identify key trial documents and protocol requirements, including Investigator's Brochures and information about Investigational Medicinal Products.
- Pharmacovigilance and Safety Reporting: Master the categorization of adverse event types and the correct reporting of safety information in clinical trials.
- Manage Investigational Medicinal Products: Acquire knowledge on the manufacture, management, storage, and dispensing of Investigational Medicinal Products and Auxiliary Medicinal Products.
- Sponsor Responsibilities, Investigator Oversight and Delegation: Understand the sponsor and investigator responsibilities in clinical trials, focusing on compliance, monitoring, reporting, delegation, and demonstrative oversight.
- Data Management and Reporting: Grasp the essentials of data management, documentation, computerized systems validation, and reporting, focusing on data integrity and legal documentation requirements.
Certification in EU Clinical Trial Regulations and Compliance
Upon successfully attending this program, you will be awarded with the Certification in EU Clinical Trial Regulations and Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally demanded and recognized, this certification will amplify your professional qualifications and demonstrate your expertise in navigating the intricacies involved in EU clinical trials regulations and compliance strategies. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.
Pricing & Registration
EU & United Kingdom
Dates: 17 - 18 Jul 2024
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 14 May 2024 | By 25 Jun 2024 | After 25 Jun 2024 | |
| EU Delegates | EUR 1,295 | EUR 1,495 | EUR 1,595 |
| UK Delegates | GBP 1,095 | GBP 1,295 | GBP 1,395 |
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 [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
- USA: +1 888 745 8875
EU Clinical Trial Regulations and Compliance Reviews and Testimonials
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.
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EU Clinical Trial Regulations and Compliance
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