Organizer: Catalyst Clinical Services Pvt. Ltd. The first company to start clinical research training in India, Catalyst is Indias largest clinical research and pharmacovigilance training organization. Over the last 16 years, more than 10,000 personnel across 27 countries have participated in specialized clinical research training offered by Catalyst.
LIVE LECTURES - ON IMPORTANT TOPICS
* New Drug Discovery Process and Clinical Research
Drug discovery process, pre-clinicai development, clinical research, clinical trial phases, stakeholders, critical success factors etc.
* Foundation to Good Clinical Practices (GCP) Guidelines
Principles of GCP, applicable GCP guidelines, evolution of GCP guidelines and responsibilities of various stakeholders (Sponsor, CRO, Investigator and Ethics Committee) etc.
* Essential Clinical Trial Documents
Protocol, Informed Consent Document (ICD), Investigator's Brochure (IB), Case Record Form (CRF), Source Data/Document (SD) etc.
* Overview of Informed Consent Process
Purpose, process requirements, essential elements, format, procedure etc.
* Serious Adverse Event (SAE) Reporting and Compensation
Adverse event, valid case, regulatory definition of serious criteria, reporting time frame and recommendations for determining compensation for study related injuries
* Regulatory Landscape
Types of applications, data requirements, New Drugs and Clinical Trials Rules (2019), National Ethical Guidelines for Biomedical and Health Research Involving Human Participant (2017) etc.
Date: 16th April 2022 (Saturday) APPLY HERE >>>
Modality: Online (Zoom Meeting)
Registration Fee: INR 2950 (before 9th April)
Certification: GCP Training Certificates will be awarded to all the participants.
Avail the early bird discounted fee. Register before 9-Apr-22
Get in touch with
Course Coordinator to register +91 9818356273, 8826806862
info@catalystclinicalservices.com
www.catalystclinicalservices.com
source https://www.pharmatutor.org/articles/workshop-on-good-clinical-practice-gcp-and-clinical-research-methodology
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