Risk Based Monitoring for GCP Compliance

Website https://www.traininng.com/webinar/-200813live?channel=ourglocal-march_2019_SEO | Edit Freely

Category online training courses for hr professionals,online training programs for hr professionals, HR Training and Development

Deadline: March 27, 2019 | Date: March 27, 2019

Venue/Country: Online Event, U.S.A

Updated: 2019-02-28 16:05:58 (GMT+9)

Call For Papers - CFP

The rationale for risk based monitoring. The requirements for risk-based monitoring and targeted source data verification (SDV) risks identification.

Critical data and risk indicators analysis. The monitoring plan including risk monitoring and centralized monitoring.

How to use risk based assessment for investigational sites and the protocol to implement risk based monitoring. Risk based monitoring roles and responsibilities.

Why should you Attend

It is essential to comply with the latest GCP requirements to have a risk based monitoring methodology for your clinical trials.

It is also essential to have a quality risk management system in place to allow for risk based monitoring. The FDA and EU regulatory authorities supports clinical trial sponsors to use risk-based site monitoring.

For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.

This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.

Areas Covered in the Session

Understand the new requirements for risk based monitoring in clinical trials

Define the regulations and guidelines which cover risk based monitoring

Review of risk based monitoring approaches and methodology for clinical trial projects

Learn how to identify and evaluate risks for the investigator site and protocol for implementing risk based monitoring

Learn how to identify critical data

Evaluate the risk indicator and set thresholds

Consider how to implement this new concept within your organization

Hear best practice of these new risk requirements

Who Will Benefit

Clinical Development Managers And Personnel

Clinical Operations Personnel

Clinical Research Associates

Clinical Research Archiving and Document Management Personnel

Quality Assurance Managers and Auditors

CROs using Laboratories to Analyze Clinical Trial Samples

Project Management

Sponsors and Non-Commercial Sponsors

Consultants

Laboratories Analyzing Samples from Clinical Trials

Regulatory Affairs Personnel

Legal and Regulatory Authorities

Speaker Profile

Dr. Laura Brown , PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.

Event link: https://www.traininng.com/webinar/-200813live?channel=ourglocal-march_2019_SEO

Contact Info

Traininng.com LLC

Email: traininngdotcomgmail.com

Phone: US: (510) 962-8903

Phone: Zurich: +41 - 43 434 80 33

Website : https://www.traininng.com