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: From large to small Pharmaceutical companies, Biotech, Medical Devices, Clinical Research Organization and Academic 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:

  • Benefit from more efficient approaches on clinical development while continuing to ensure human subject protection and data       integrity.
  • Become familiar with the new clinical research process such as risk quality management systems.
  • Understand the drivers of risk-based monitoring planning and implementation.
  • Know how to align sponsor responsibilities with clinical research organizations duties, by a synergistic collaboration of several       functions with a variety of external stakeholders.
  • Learn why and how new clinical trials guidelines and regulations contribute to success in an environment that changed dramatically       due to new technologies.
  • Be armed with a box full of tools and case studies you can use back in the office.

Meet your Prominent Facilitator

Jan
Anna Gibernau
Executive Director at Clementine Global

Executive Director, Clementine Global S.L., specialized in development of new molecules and therapies, with wide experience from early development to commercialization, from small biotech, medical devices to large pharmaceutical organizations. Driven clinical trials in wide range of clinical indications in Europe, USA, Latam and Asia Pacific in multiple indications such as oncology, neuroscience, cardiovascular, vaccines, metabolic and infectious diseases from phase 0 to IV. Proven expertise to execute clinical trials with risk-based approach, 6σ and PMI methodology, to cut down investment costs while maintaining quality across project life cycle.
Since 1988, she has assumed multiple roles at Pharma Industry (Boiron, Parke Davis, Cusí, BieffeMedital) and Clinical Research Organizations (CDC, Ingenix-i3, inVentiv and MedSIR), from Technical Director, Quality Control & Assurance and Clinical Research Operations Management.During the last 20 years she has managed clinical trials for more than 23 pharma & biotech companies worldwide PhD in Pharmacy, she initiated her career on clinical research after her Master of Science in Biopharmacy at King’s College (UK). Additional degrees include the Executive Educational Program at Wharton Business School, Six Sigma Green Belt Award within the Corporate Quality Improvement at UHG and PMP® certification at Project Management Institute® (USA). Since 2001 she has been lecturer at Barcelona University, IUSC and other international organizations on Good Clinical Practices. Currently she collaborates as Scientific Director of the Master on Clinical Research and Medical Affairs organized by CESIF.

Registration Online

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

Antwerp, Belgium