EU's New Regulation 536/2014 on Clinical Trials

Description

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.

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 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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