Join Viedoc at Ferring International PharmaScience Center in Copenhagen on Thursday, December 8th, where we will discuss the critical role of eClinical solutions in today's clinical trials, key aspects of Good Clinical Practice (GCP) inspection of eClinical systems, stress the importance of compliance, and demonstrate how Viedoc leads the market in this area.

Preparing for GCP inspection can be made easier and more efficient through your eClinical solution. During this event, two industry experts will give you a clear overview of eClinical regulations and how Viedoc maintains compliance.

 

Agenda

  • 14:00 – 14:30 – Networking and coffee
  • 14:30 – 14:45 – Introduction by Ferring and Viedoc
  • 14:45 – 15:30 – Philip Lange Møller on GCP and data management
  • 15:35 – 16:15 – Alan Yeomans on how Viedoc maintains compliance
  • 16:30 – 18:30 – Happy hour

 

Details

 

Register

Overview

Part I — Overview of eClinical regulations

  • What regulatory considerations to keep in mind when selecting an eClinical solution
  • What regulatory inspectors will look for when inspecting a company’s eClinical solution
  • What is expected of the company
  • What companies have to provide

Part II — How Viedoc ensures compliance

  • Presentation on Viedoc’s GCP compliance
  • How Viedoc continues to innovate with regular releases while guaranteeing compliance and validation
  • The importance of the Viedoc Inspection Readiness Packet and how it helps customers during a GCP inspection

Speakers

Alan Yeomans

Alan has been Viedoc’s Regulatory Affairs Manager for 14 years while also serving as Quality Manager and an industry expert in Quality Assurance in the pharmaceuticals industry—including experience with Requirements Analysis, Agile Methodologies, and Quality Management. Alan holds a Bachelor of Engineering in Electronics from The University of Western Australia.

Connect with Alan on LinkedIn

Philip Lange Møller

In September 2018, Philip founded the company GCP Mock Inspection Service ApS as an independent consultant, giving GCP advice, conducting audits, and leading mock inspections for clients. With experience as a Medicines Inspector at the Danish Medicines Agency and as a member of the EMA GCP Inspectors Working Group, Philip is well-versed in regulations and compliance within the clinical research space. Philip holds a degree in Medicine from Aarhus University and trained in internal medicine and anesthesia until 1997.

Connect with Philip on LinkedIn