€320 – €840

Biostatistics Methodology for Regulatory Submissions

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Betriebsgesellschaft mbH Kärntner Straße 22

A-1010 Vienna


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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.


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


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


  • 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

THE INSTRUCTOR - Thomas Zwingers

Thomas Zwingers is Head of Statistical Consultancy for CROS NT, a global CRO with offices in the UK, Germany, Italy and the US. In his current role, Thomas provides pharma, biotech and medical device companies with statistical methodology advice pertaining to trial design, conduct and reporting including regulatory submission, and has presented statistical findings to the European Medicines Agency on numerous occasions. Thomas has been working in the clinical trial environment since 1980 in project team management and statistical analysis. He specializes in statistical analysis and reporting with particular expertise in Adaptive Trial Design and Non-Inferiority Trials.

Prior to joining CROS NT, Thomas has an independent statistical consultant who ran his own biometrics CRO in Germany for over 20 years. During this time, he gained a considerable amount of experience in Dermatology, Respiratory and Oncology studies, and has particular expertise in applying adaptive designs to oncology trials.

CROS NT proudly supports Wings For Life Fundthroughout 2017. In occasion of this course, CROS Academy will donate 20 EUR for every participant in honor of Wings For Life.

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