PPH plus Webinar on QbD & Risk-based Approach in Clinical Trials

During the 1-hour webinar, Dr. María Proupín-Pérez, Project Leader at PPH plus, will tackle the following topics:

  • Quality & management issues in clinical trials nowadays
  • Improvement of clinical trial designs (design space) by means of quality by design
  • Risk-based quality management in clinical trials as per the draft version of the addendum to the ICH GCP guideline
  • Risk identification & assessment – risk prioritization
  • Risk identification tools
  • Risk prioritization tools
  • Risk monitoring & control
  • Risk reporting

This webinar is describing the reason for and objectives of the risk-based approach in clinical studies. The recorded training session provides streamlined guidance on how QbD and the risk-based approach complement each other to enhance quality in clinical trials.

This webinar is of special interest for clinical trial management, quality management and risk management functions in biopharma, CROs and clinical research institutions.

ICH GCP Goes Risk-based

The ICH Working Group embraces the risk-based approach to keep pace with the ever growing clinical trials complexity, regulatory constraints as well as with the availability of new technologies. PPH plus and Cyntegrity Germany offer an expert webinar on the imminent changes in drug development procedures as per the recently released draft addendum to the ICH GCP guideline.

The topic is aligned with the recent announcement of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation, of the reinforcement of the ICH foundation “to make it better-equipped to face the challenges of global pharmaceutical development and regulation”.

During the 60-minute webinar, Dr. María Proupín-Pérez, Project Leader at PPH plus GmbH & Co. KG, and Dr. Artem Andrianov, Managing Director at Cyntegrity Germany GmbH, will provide a structured summary and critical review of the draft version of the ICH GCP guideline focusing on changes in:

  • Trial designs
  • Planning processes
  • Quality management system (QMS)
  • Trial oversight procedures
  • Data collection and reporting procedures

RbM: from Idea to Implementation


This webinar is directed to the whole spectrum of clinical research professionals from biopharma, CROs, and research institutions and organizations, who wish to learn how to plan and improve their clinical studies by means of risk-based management.

During the 1-hour complimentary webinar, Dr. María Proupín-Pérez, Project Leader at PPH plus, will start the learning session tackling the following topics:

  • How to improve risk awareness and mitigation from clinical study planning
  • What the basis for adaptive risk-based monitoring is
  • How RbM enhances time and financial control
  • How RbM optimizes operational productivity

Dr. Artem Andrianov, Managing Director at Cyntegrity Germany GmbH, will complement the agenda with technologic managerial aspects from his vision as a software expert:

  • What the next upcoming ICH GCP change will bring
  • How to construct a good risk-defense strategy for your trial
  • What technical solutions for RbM exist and how they differ
  • What the steps for embracing RbM are and how to plan the transition period