EU's New Regulation 535/2014 on Clinical Trials

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EU's New Regulation 535/2014 on Clinical Trials

October 17, Tuesday 10:00 AM PDT | 01:00 PM EDT Duration: 90 Min

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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, guidances, etc. Finally the product must be tried out on humans / patients in a tightly controlled environmnent.


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.

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 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

Instructor Profile:

    Kelly Thomas
    Vice President, Americas Quality Operations

    Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

    Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.