EU's New Regulation 535/2014 on Clinical Trials to 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.
Clinical 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:
This webinar will focus on the new 2022 EU regulatory requirements for clinical trials, with the 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 the 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 the 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.Areas Covered in the Webinar:
Principal, J E Lincoln and Associates
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 as a full-time 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. 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. John is a graduate of UCLA.
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Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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