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Clinical Trials Regulations With ICH GCP E6 R2 Workshop

clinical research associate training

Clinical Trials Event Date 22– 24 October, Location – Amsterdam, The Netherland

MASTERCLASS OVERVIEW ON worldwide clinical trials

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 and clinical trial protocols. Understand how the new guidelines and regulations allow clinical trial research taking strategic decisions that benefit your organization’s success.

TARGET INDUSTRY OF THIS CLINICAL TRAINING:

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

WHO SHOULD ATTEND CLINICAL TRIALS TRAINING?

  • Clinical Development Manager should attend this clinical trials training
  • Clinical Operations Manager should attend this clinical trials training
  • Director Clinical Development should attend this clinical trials training
  • Director Clinical Operations should attend this clinical trials training
  • Head Of Clinical Operations should attend this clinical trials training
  • Head Of Regulatory Affairs should attend this clinical trials training
  • Regulatory Affairs Officer should attend this clinical trials training in Europe
  • Senior Manager Clinical Operations should attend this clinical trials training in Europe
  • Vice President Clinical Development should attend this clinical trials training in Europe
  • Senior Regulatory Affairs Specialist should attend this clinical trials training in Europe
  • Senior Clinical Trial Manager should attend this clinical trials training in Europe
  • Head Of Clinical Operations should attend this clinical trials training in Europe
  • Project Team Lead should attend this clinical trials training in Europe

KEY TOPICS OF CLINICAL TRIAL REGULATION MASTERCLASS EUROPE

  • You will learn about risk assessment in this clinical trials training
  • Risk management
  • Risk-based monitoring
  • Central monitoring is also one of the topics which you will learn about in this clinical trials training
  • Safety reporting is one of the major points you will understand in this clinical trials masterclass
  • Computerized systems
  • Training on Validation of computerized systems
  • IMP handling according to GCP training
  • EU Annex 13 is a very famous topic which will be discussed in this clinical trials masterclass
  • Sponsor & investigator oversight training
  • Training to discover important developments such as Risk based approaches to trial management & oversight.
  • Training to develop GCP problem-solving skills by considering the most common problems encountered in clinical trials.
  • Have a complete understanding of different processes in the clinical trials industry
  • Explore the most important rules related to the handling of clinical trial data.
  • Training to understand  trial master file requirements

KEY BENEFITS (Clinical Research Associate Training)

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

Registration Fee


€2496


Per Participant


About Amsterdam

Amsterdam is the Netherlands’ capital, known for its artistic heritage, elaborate canal system and narrow houses with gabled facades, legacies of the city’s 17th-century Golden Age.

You may also be interested in our Food Fraud & Authenticity Masterclass

We also organize In-house training session on this topic, so if you are looking for In-house training in Clinical Trials Regulations then click here. We Deliver In-house training for Clinical Trials Regulations in all countries and all time zones

Start Time

9:00 am

October 22, 2019

Finish Time

5:00 pm

October 24, 2019

Address

Amsterdam, The Netherlands

Our Facilitator