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Nov 28
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08:00 - 09:00 60 mins
09:00 - 09:10 10 mins
Chairpersons Opening Remarks
09:10 - 09:40 30 mins
FiH Regulator Perspective: Practical feedback following 7 months of implementation
  • Latest updates and feedback on first studies under the FiH guideline
  • Guidance on filing IND or clinical trial application packages
  • Expectations on justifying first dose selection
  • How to avoid regulators requesting lower starting doses and increasing time spent in early phase
09:40 - 10:10 30 mins
FiH Industry Perspective: First experiences with the new First in Human guideline
  • Henrik Forsman - Director Scientific Project Management, AstraZeneca
  • Experiences on the impact on progression speed of early phase studies
  • Case examples of managing risk in FiH studies
  • Discussion of operational challenges related to the FiH guideline and how to overcome
  • Does the guideline have a positive effect on early phase clinical trials?
10:10 - 10:40 30 mins
Early Phase Regulations Panel Discussion
  • Lene Grejs Petersen - Senior Advisor, Danish Medicines Agency
  • What common mistakes are made by industry and what can be done to stop them?
  • What changes have been suggested following the first months of implementation of the FiH guideline?
  • What is the latest status of the Clinical Trial Regulation and how will it impact early phase clinical development?
10:40 - 11:30 50 mins
Morning coffee and networking
11:30 - 12:30 60 mins
PANEL DISCUSSION: Conducting early clinical development in the global environment: Practical advice for dealing with regional guidelines
  • Colette Strnadova - Senior Scientific Advisor, Health Canada, Canada
  • Experiences with conducting early phase trials outside of Europe
  • What are the pros and cons of conducting early phase trials in countries with different regulations?
  • Comparing the FiH guideline to regulations in other parts of the world
  • Explorations of China’s standpoint on early phase
  • How could Europe play an international role?
12:30 - 13:00 30 mins
Spotlight session – Adaptive trial design
  • A Representative from MAC plc - -, MAC plc, UK
13:00 - 14:30 90 mins
14:30 - 15:00 30 mins
A regulatory perspective on blood pressure assessments in phase I and II trials: Ambulatory blood pressure monitoring and other approaches
  • Colette Strnadova - Senior Scientific Advisor, Health Canada, Canada
15:00 - 15:30 30 mins
Spotlight session – Ensuring patient safety in early clinical trials
  • A Representative from Alta Sciences - -, Alta Sciences, Canada
  • Practical examples of approaching risk assessment without existing pharmacovigilance data
  • Clinical and preclinical safety functions and how to integrate these into study design to reduce risk
  • How to minimise risk without spending too much time in early phases
15:30 - 16:00 30 mins
Afternoon break
16:00 - 16:30 30 mins
Putting the patient first: Practically applying a patient centric approach to early phase study design
  • Wolfgang Eglmeier - Head Centre for Clinical Studies, Witten/Herdecke University, Germany
16:30 - 17:00 30 mins
Challenges in early phase patient recruitment and ensuring representative populations
  • Understanding how to ensure the most realistic population possible
  • Defining the right endpoints for more efficient population samples
  • Selecting patient populations to prevent side effects from only showing in later phases
  • Practical advice on streamlining recruitment processes to reduce cost and time
17:00 - 18:00 60 mins
PANEL DISCUSSION: Patient recruitment for special populations: paediatrics, geriatrics, and oncology
18:00 - 18:05 5 mins
End of Conference Day One