Clinical Trial Design & Quality

    12 – 13 October 2023, live online training


    Planning of clinical trials to support a marketing authorisation must take into account many aspects from study design to regulatory requirements and feasibility. This course aims at an overview for attendants, that have already some basic experience in the field of clinical trials. However, in many clinical settings the usual standard approach of Phase 1 to 4 and standard methodology will not be applicable. This course will provide additional hints on how to develop specific strategies adapted to such situations in a case study-based approach.

    Learning Objectives

    • Understand regulatory expectations
    • How to tailor a study design to fit the most relevant rationale
    • How to develop a strategy when a fully powered, randomized, double blinded, placebo-controlled trial is not feasible
    • How to choose endpoints
    • How to choose comparators
    • How to select an appropriate patient population
    • How to demonstrate evidence beyond safety/efficacy

    Key Topics

    • Criteria to choose appropriate endpoints
    • Clinical relevance of an outcome vs. statistical significance, estimands
    • Comparators: placebo, active, head-to head vs on top of, roll over, delayed onset, randomized withdrawal
    • Label claim: homogeneous vs representative study populations
    • Dose justification and flexible dosing
    • How to demonstrate significant benefit, relative effectiveness, and other more specific study rationales, estimands
    • How to address ethical & compliance Issues
    • Methodological considerations
    • Problems of limited patient populations & new diseases
    • Role/problems of historical data
    • Problems with blinding, open label designs
    • Supportive data from outside clinical trial settings, real world evidence and registries
    • Extrapolation and modelling/simulation approaches

    Who should attend?

    • Clinical Research Associates
    • Clinical Scientists
    • Clinical Operations Analysts
    • Clinical Diagnostic Specialists
    • Clinical Trial Managers
    • Regulatory Managers & Specialists
    • Quality & Compliance Associates

    Past participants

    • Clinical Project Scientist, Idorsia
    • Sr. Director Clinical Development Leader, Teva
    • Clinical Operations Manager, Gilead Sciences
    • Early Development Scientist, Boehringer Ingelheim
    • Director Clinical Scientist, Jenssen Biologics
    • Senior Director Clinical Operations, Fresenius Kabi
    • Trainee Clinical Science, Johnson & Johnson
    • VP, Head of Regulatory Science, Oxford Biomedica
    • Regulatory Affairs Manager, OM Pharma
    • Global Trial Manager, Novo Nordisk
    • Regulatory Strategist, Merck Healthcare

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies.
    Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.

    Clinical Trial Design & Quality

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 781 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      12. October 2023
      02:00 PM Vienna time
      01:00 PM London time
      08:00 AM New York time
      05:00 AM Los Angeles time
    • End Date
      13. October 2023
    What participants said about this course

    "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot."
    Senior Development Pharmacist, Orion Corporation

    "Keep up the excellent standard of training courses!"
    FDF Industrialisation Manager, Medichem Manufacturing

    "I have received a lot of knowledge that will be of big use for my profession."
    Quality manager, Vironova AB

    "Thank you for a very informative training course. The timing of start/break/finish was perfect."
    Clinical Project Manager, Regen Lab

    "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks."
    Head of API and Contract Manufacturing, Zentiva Group

    "Very informative and memorable training course for me."
    Quality Vice President, Darou Pakhsh

    "The trainer was very knowledgeable about the topics and was able to answer all questions."
    Drug Product Subject Matter Expert, Pfizer