EU's New Regulation 536/2014 on Clinical Trials

EU's New Regulation 536/2014 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.

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Last Recorded Date: Oct-2023

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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:

  • 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.
Why Should You Attend:

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:
  • 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
  • Deliverables.
  • Subject safety
Who Will Benefit:
  • Marketing
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All personnel 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.
Instructor Profile:
John E Lincoln John E Lincoln

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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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