Cambridge Healthtech Institute’s 3rd Annual

Risk-Based Quality Management

Integrating Quality into Clinical Trials to Ensure Effective Monitoring

14-15 October 2020

 

We are pleased to announce production of Cambridge Healthtech Institute’s Risk-Based Quality Management: Integrating Quality into Clinical Trials to Ensure Effective Monitoring being held 14-15 October 2020 at the Hotel Barceló Sants in Barcelona, Spain. With no industry golden standard of risk management available and the current push from regulatory authorities to implement, this leaves most companies in a precarious position and with many questions. What should be measured and reviewed to ensure the process is being implemented according to the plan? What metrics could be used to provide insights about the process and future process improvements? Am I consistent with ICH E6 (R2) and ICH E8 (R1)?

The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, 5 conferences focused on specific issues and functions within the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2020. Topics to be discussed at the Risk-Based Quality Management conference include

  • Quality management
  • Central monitoring
  • RBM in novel trials
  • Lessons learned from joint inspections
  • Using AI/ML for RBM
  • Preparing for regulatory changes, ICH E6 R2 and ICH E8 R1

If you are interested in presenting, please submit a speaking proposal for review by 20 March 2020.

We are looking for actual implementation stories and lessons learned, not theoretical talks. Co-presentations featuring speakers from different departments involved in the project are encouraged.

Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academic/hospital centers. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

The deadline for priority consideration is 20 March 2020.

For more details on the conference, please contact:
Mana Chandhok
Producer, Conferences
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1350
Email: mchandhok@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K:
Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5457
Email: iquigley@healthtech.com

Companies L-Z:

Patty Rose
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349
Email: prose@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5456
Email: rhandy@healthtech.com