Biostatistics Concepts and  Methodology for Regulatory  Submissions
€320 – €840
Biostatistics Concepts and  Methodology for Regulatory  Submissions

Biostatistics Concepts and Methodology for Regulatory Submissions

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Hotel Metropole Geneve

Quai du Général-Guisan 34

Genève, Switzerland

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INTRODUCTION

The publication in 1998 of ICH E9 guidance on Statistical Principles in Clinical Trials brought a degree of clarity and harmonization to the statistical requirements of the major regulatory authorities.  Since that time the FDA and EMA have issued a further twelve guidance documents and have developed certain standard approaches which are not well-documented. 

In this course a statistician experienced in interacting with both the FDA and EMA will identify the key issues of concern to regulatory authorities and will focus on ways to design and analyse clinical trials to avoid or minimize the impact of these issues.

COURSE OBJECTIVES

After this course, participants will be able to:

  • Understand the main statistical issues of concern to regulators

  • Work with statisticians to Identify ways to design and analyse trials to avoid these issues arising

  • Comprehend statistical and regulatory aspects of Integrated Summaries of Safety & Efficacy


FOR WHOM IS THIS COURSE DESIGNED?

The course will be suitable for anyone with basic knowledge of statistical issues in clinical drug development, such as:

  • Medical Directors and Medical Affairs professionals

  • Heads of Clinical Operations with limited statistical knowledge

  • Clinical professionals in Pharmaceutical, Biotechnology or Medical Device Companies

  • Regulatory professionals in Pharmaceutical, Biotechnology or Medical Device Companies

  • Biostatisticians with limited knowledge of regulatory activities

  • Outsourcing managers

AGENDA

  • 08:30 - 09:00: Welcome and Registration

  • 09:00 - 09:45: Regulatory Guidance on Statistical Topics

  • 09:45 - 10:30: Objectives of a Study - Primary Outcome, Estimands and the Problem of Multiplicity

  • 10:30 - 10:45: Morning Coffee Break

  • 10:45 - 11:30: Dealing with Multiplicity

  • 11:30 - 12:30: Non-Inferiority Trials - Choice of Margin

  • 12:30 - 14:00: Lunch

  • 14:00 - 14:45: Analysis Populations- what patients do we include?

  • 14:45 - 15:30: How to handle missing data - including sensitivity analysis

  • 15:30 - 15:45: Afternoon Coffee Break

  • 15:45 - 16:30: Subgroup Analyses

  • 16:30 - 17:15: Specific guidance for oncology trials

  • 17:15 - 18:00: Questions and Answers


INSTRUCTOR

THOMAS ZWINGERS, Head of Statistical Consultancy for CROS NT

Thomas Zwingers is the Head of Statistical Consultancy for CROS NT, a global CRO specialized in biometrics services. In his current role, Thomas provides Sponsors with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submission. He has presented findings to the European Medicine Agency (EMA) on numerous occasions and provided consultancy for FDA submissions. Thomas has been working in the clinical trial environment for over 35 years in statistical analysis and project team management. He specializes in Adaptive Trial Design, especially in the area of Oncology, and Non-Inferiority Trials. Prior to joining CROS NT, Thomas ran a clinical data services CRO in Germany for 20 years. He is currently based in Augsburg/Munich area, Germany.

CROS ACADEMY FOR WCRF

CROS NT proudly supports the World Cancer Research Fund throughout 2016. In occasion of this course, CROS Academy will donate 20 EUR for every participant in honor of WCRF.

ABOUT WCRF: World Cancer Research Fund International is the world’s leading authority on the link between diet, weight, physical activity and cancer. Their vision is to live in a world where no one develops a preventable cancer. More information on www.wcrf.org 

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Hotel Metropole Geneve

Quai du Général-Guisan 34

Genève, Switzerland

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