Preconference Short Courses

All 2019 short courses will occur the afternoon of 4 February at 14:00- 17:30 and require separate registration. Please click the "Learn More" button under each course to see more details and to register.

• Benefit-Risk Management Methodologies
• European Regulatory Meetings – How to Best Prepare and Perform
• Effective Global Quality Management System and Product Safety
• The Evolving Disclosure/Transparency Landscape (Workshop)
• Fostering Patient Centricity by Improving Lay Language Communications
• In Development

• Benefit-Risk Management Methodologies

  Instructor: Michael Forstner, PhD, Senior Vice President, Head of Risk Management and Pharmacoepidemiology, PrimeVigilance, Switzerland

  This course aims to provide an opportunity to explore different methods in order to foster a more frequent and systematic utilisation of methods enhancing the transparency around Benefit Risk decision making. We will introduce methods for the analysis of risk factors contributing to the development of (potential) risks (Zurich Hazard Analysis, Fault Tree Analysis), the analysis of risks associated with medication processes leading to potential medication errors (Failure Modes and Effects Analysis), Qualitative Benefit Risk frameworks, as well as discuss the possible uses for Quantitative Benefit Risk analysis methods.

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• European Regulatory Meetings - How to Best Prepare and Perform

  Instructor: Steffen Thirstrup, MD, PhD, Director, NDA Regulatory Advisory Board, NDA Advisory Services, United Kingdom

  This short course focuses on how best to plan, manage, prepare and execute successfully at EU high stakes meetings. Former CHMP members, pharma executives and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators. Focus will be on CHMP oral explanation but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimise the stress on your team will also be touch upon.

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• Effective Global Quality Management System and Product Safety

  Instructor: Brian Edwards, DrMed, Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom

  The Quality Management System (QMS) for pharmacovigilance has implications for other areas of GXP such as GMP, GLP, GCP, GDP and so we will discuss how we can integrate compliance and quality under one QMS. Not all companies take this approach and yet it is surely the most efficient as ultimately safety is the underlying purpose. This collaborative approach enables a company-wide approach to topics such as metrics and key performance indicators. We will share experiences and provide best practice on how to enhance QM systems and explain how implementing the right strategies from data collection and management leads to informed decisions to create better inputs into public health.

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• The Evolving Disclosure/Transparency Landscape (Workshop)

  Instructors:

  • Merete Joergensen, MBA, MSc, Senior Trial Disclosure Director, Global Clinical Registry, Novo Nordisk A/S, Denmark
  • Robert Paarlberg, MS, Principal, Paarlberg & Associates LLC, United States

  This course will cover the key disclosure and transparency requirements and background information on how the requirements have evolved from 2004-2018. The topics to be covered are:

  • The evolution from ICMJE requirements in 2004 to today’s requirements for sharing of clinical study documents in relation to regulatory submissions
  • The outside influencers and internal stakeholders – who are they?
  • A deeper dig into the EU and US requirements, similarities and differences
  • Highlights of the FDA Amendments Act Final Rule expanding reporting requirements in ClinicalTrials.gov
  • The global environment of local and primary WHO registers

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• Fostering Patient Centricity by Improving Lay Language Communications

  Instructor: Thomas M. Schindler, PhD, Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co.KG, Germany

  The idea of this short course is for participants to learn from experiences on how to conduct communication with trial participants. The work of the TransCelerate Information Exchange sub-team may serve as a starting point for establishing more patient focused interactions. An important part of patient focus is that the written interactions observe the rules of lay language communication. Lay summaries may serve as an advanced example of structured information in lay language. The course will highlight the various communication points between study sponsor and participant. It will also show the importance of communicating in lay language to strengthen the sponsor - participant relationship.

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• In Development

  Details to be confirmed shortly.

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