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EUs New Regulation 535-2014 on Clinical Trials
- Clinical trial basis
- Participant safety issues
- EU's New Regulation 535/2014 on Clinical Trials
- Roles and responsibilities
- Documentation requirements: Before, during, and after
- Trial administration
- Key steps in the clinical trial
- Deliverables.
- Subject safety
Overview of the webinar
linical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.
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.
Who should attend?
Why should you attend?
EU's New Regulation 535/2014 on Clinical TrialsTo establish that a drug or device is safe and effective, tests are required. There are many preliminary tests, including lab tests, standards, guidance, etc. Finally, the product must be tried out on humans/patients in a tightly controlled environment.
This webinar will focus on the new 2022 EU regulatory requirements for clinical trials, with a focus on drugs. The new rules further ensure that there are rules and terms outlined in the protocol to result in valid data to be used to evaluate the subject of the trial. Participants and researchers, doctors, and health practitioners all must agree to the terms of the study as outlined in the protocol. All must understand the risks involved. The professionals who manage and administer the trials must follow the strict regulatory rules for clinical trials set by government agencies. These rules make sure that those who agree to participate are treated as safely as possible, and that the outcomes are scientifically arrived at.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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 including 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 ptublished 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.