Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation
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Price: $225.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Streamline your path to multi-country trial approval with a single electronic application. This course demystifies the EU Clinical Trials Regulation, helping you gain authorization across the EEA efficiently.
Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:The Clinical Trials Regulation and its context This session describes how medicines are regulated in the EEA, identifies key characteristics of the Clinical Trials Regulation (CTR), and specifies its applicability to clinical investigations. It identifies EU online portals and databases relevant to clinical trials and describes the Clinical Trials Information System (CTIS), which is essential to the authorization and supervision of trials under the CTR. It discusses the concept of low-intervention clinical trial. Finally, it explains how requirements vary during the period of transition from the Clinical Trials Directive to the CTR. Making a clinical trial application This session explains how to register to use the CTIS, the distinction between Parts I and II of an application, how a reporting member state (RMS) is appointed, and how to make a full or partial submission of a clinical trial application (CTA). It identifies the contents of a CTA dossier and explains how to apply for deferral of publication of certain contents. It describes relationships among the clinical protocol, investigator's brochure, and investigational medicinal product dossier, and explains where the reference safety information should appear. It also specifies requirements that must be met by clinical and nonclinical data in applications. Assessment of application This session explains how each part of a CTA is validated and assessed by the RMS and other member states concerned (MSCs) in the application. It specifies the sequence of procedures and the deadlines that have to be met by the MSCs and, in the case of requests for information, by the sponsor. It sets out the various decisions on authorization that may be the outcome of assessment. Assessment Multiple-choice mastery assessment. | Objectives:Who will benefit from this module? Regulatory affairs professionals, clinical development staff, and healthcare professionals who sponsor or participate in clinical trials will benefit from this module. Learning objectives
Audience: Regulatory affairs professionals, clinical development staff, healthcare professionals Category: Clinical trials, regulatory affairs Region: Europe Level: Introductory/intermediate | |
 | Regulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramProgram ID: GCP00A2Price: $1295.00 (USD) |
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