EU's New Regulation 536/2014 on Clinical Trials is designed to establish the safety and effectiveness of drugs and devices through rigorous testing. Join the webinar to explore the essential preliminary tests, standards, and guidelines necessary before a product can be trialed on human subjects in a tightly controlled environment.
Clinical trials play a crucial role in advancing medical knowledge and improving healthcare outcomes. Through these carefully planned research studies, volunteers help uncover answers to critical health questions, paving the way for new treatments and advancements in patient care.
- Clinical trials are conducted according to a plan, called a protocol, which describes:
- The types of patients who may enter the study
- The schedules of tests and procedures
- The drug involved
- The dosages, or amount of the drug used by patient
- The length of the study
- What the researchers (sponsor) hope to learn from the study. All such trials are to be conducted under strick rules, such as this new EU Regulation.
During this webinar, we will delve into the 2022 EU regulatory requirements specifically focused on clinical trials, emphasizing drug-related trials. Our expert will guide you through the key aspects of the new rules, highlighting the importance of well-defined protocols to ensure the generation of valid and reliable data. We will explore the critical elements outlined in the protocols, including patient selection criteria, test schedules, drug administration details, study duration, and the intended research goals.
Why You Should Attend:
By attending this webinar, you will Gain comprehensive insights into the 2022 EU regulatory requirements for clinical trials, with a focus on drug-related trials. Understand the critical elements of well-defined protocols and their role in generating valid and reliable data. Discover the responsibilities of professionals involved in managing and administering clinical trials. Learn how adherence to strict regulatory rules safeguards participant safety and ensures scientifically sound outcomes. Stay up-to-date with the latest developments in EU clinical trial regulations and contribute to the advancement of medical research.
Areas Covered in the Session :
- Clinical trial basis
- Participant safety issues
- EU's New Regulation 536/2014 on Clinical Trials
- Roles and responsibilities
- Documentation requirements: Before, during, and after
- Trial administration
- Key steps in the clinical trial
- Subject safety
Who Should Attend:
- Quality Assurance Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Engineering Departments
- Production Departments
- Senior Management
- Everyone involved in EU Clinical Trials, especially those involved in new product (maily drug) development, and changes, as to the need for clinical trials held in the EU
Course Director: JOHN E. LINCOLN
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.