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Meet the training leader

  • Julianne Hull BSc MSc
  • Consultant and Trainer in Pharma Industry
  • United Kingdom
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Course description

The pharmaceutical industry is aware that the International Council for Harmonisation is planning to merge the guidelines for Good Clinical Practice (E6) and General Considerations for Clinical Trials (E8). To prepare for this change in 2022 it behoves all clinical trial professions to ensure they are working to the latest expectations when managing their clinical programmes.

Key Topics

Project definition

Project risk analysis, issue management and CAPA

Prioritization during your clinical trials projects

Effective study feasibility

Study enrolment plan & patient recruitment challenges

Safety monitoring

Budget planning & management

Protocol adherence during COVID-19 pandemic

Inspection ready clinical trials

Management of vendors, CROs and subcontractors s

Tracking timelines & measuring the progress of your projects

Project close out

Key takeaways

Learn how detailed upfront preparation leads to success

Understand the importance of a motivated team with clear priorities

Construct an effective team approach to Quality by Design

Operate a transparent issue management process without micromanagement

Deliver inspection ready clinical trials

In partnership with

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Volt Pharma Associates (VPA) is an associate network of world-class BioPharmaceutical consultants and subject matter experts. We help our clients by using our combined experience and industry best practice to design and deliver innovative solutions across the entire biopharmaceutical value chain. Our independent “hands-on” approach helps our clients to release the full potential of their products, organisations & people. We are dedicated to the consistent delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment, transparency and knowledge sharing.

Tickets

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