Masterclass Overview

Complexity and cost of clinical trials have increased dramatically in recent years. Learn how evolutions in technology and risk management process offer new opportunities to increase efficiency and focus on relevant activities. Understand how the new guidelines and regulations allow taking strategic decisions that benefit your organization’s success.

Target Industry: Clinical Research Organizations, Biotech companies, Clinical Research Services Suppliers, Large to small Pharmaceutical companies, Non-Commercial Research Organizations.

WHO SHOULD ATTEND?
  • Clinical Operations Directors
  • Project Managers
  • Clinical Project Leads
  • Clinical Research Associates
  • Clinical Research & Development
  • Clinical Data Management
  • Clinical IT
  • Clinical Trials
  • Medical Affairs
  • Regulatory Affairs
  • Compliance
  • Quality control / Assurance/GCP
  • Clinical Study Design
  • Safety Surveillance
KEY TOPICS
  • Risk Based Quality Management Systems
  • Centralised Monitoring
  • Risk Based Monitoring
  • CRO & Vendors Oversight
  • Validation Computerized Systems
  • Risk Process
  • Data protection
  • Essential Documents
KEY BENEFITS

By attending this course, participants will:

  • Learn the practical implications of the new regulatory requirements for clinical trials, including ICH E6(R2) and the EU Clinical Trials       Regulation
  • Be able to implement more efficient, risk proportionate approaches for clinical trials while continuing to ensure human subject       protection and data integrity
  • Learn to analyze risks in clinical trials and implement risk mitigation plans including monitoring plans
  • Demonstrate sponsor oversight in line with regulatory requirements and Regulatory Agency expectations
  • Plan and prepare for inspections and respond to inspection findings

Meet your Prominent Facilitator

Jo
Jo Burmester
Clinical Research Training Consultant

Jo is a pharmacology graduate and began her career in clinical research in 1987. She worked as a CRA and senior CRA for 5 years before moving into a full time clinical research training role in 1992.
She has designed and delivered clinical research and soft skills training for a wide variety of audiences and has managed training departments in two global organizations. Her career has included experience in the pharmaceutical industry (Glaxo, Lederle and Wellcome) and the CRO world (ClinTrials Research and Quintiles) and she has worked internationally, covering both ICH and FDA requirements.
She was a founding Director of Pharma School for 14 years, and is now the CEO of JoBurmester.com. She holds a Certificate in Training and Development from the Chartered Institute of Personnel and Development, was a Module Leader on the MSc Program run at Liverpool John Moore’s University. She regularly chairs and speaks at international clinical research conferences and is the author of a book on Continuing Professional Development.

Payment Online

Registration Fee

€2596

  • Per Participant

Pay Now

In-house Trainings

  • Specific industries face specific problems. They require niche information and solutions. In-House Training is precisely engineered to your needs.

  • Taking place in the privacy of your company, including real-life case studies and best practices, the course is led by an independent industry expert.

  • We have the best subject matter experts (empanelled with us) globally which further help us to draft agenda in line of needs & which is delivered at the convenient time & venue to you.

  • Provide your employees a unique learning experience without having to leave the office, interruption of work and duties & incurring travel costs.

If you want to send us an email with your query, just send it to: masterclass.registrations@aurelius.in

Masterclass Venue

+44 2032 398083

Amsterdam, the Netherlands