Effective Implementation of the Revised EMA First-in-Human (FIH) Guidance to Accelerate Your Early Clinical Development

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • January 16, 2018 | (Tuesday) 10:00am EST / 3:00pm GMT (UK) / 4:00pm CET (EU-Central)
  • 60 min

In this webinar the speakers will discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency.

Attendees will learn how to combine multiple standard trials in one protocol, including SAD, MAD, food effect, age and gender, and efficacy in patients.

In addition, key aspects of the revised EMA First-in-Human guidance will be considered in order to design suitably-flexible protocols to avoid unnecessary regulatory delays. Pros and cons of conducting early phase research in the EU will also be discussed, along with the acceptability of clinical trial data from trials run in the EU by other agencies.

 

Speakers

Dr. Annelize Koch, MBChB, FFPM, Medical Director, Simbec Research

Annelize has over 15 years of experience in the drug development process, including interpretation of preclinical pharmacology/toxicology, Phase I (including first-in-human) pharmacology/PK studies and Phase IIa trials. In addition to her medical degree, Annelize also holds a Certificate of Completion of Training (CCT) in Pharmaceutical Medicine (Royal College of Physicians) and is a Fellow of the Faculty of Pharmaceutical Medicine. Annelize has extensive experience in the running of Phase I studies as well as scientific knowledge of the design and management of clinical studies. Annelize has held medical positions at Paraxel and GSK.

 

Dr. Simon Hutchings, MPharmacol PhD CHP, Director Scientific Affairs, Simbec Research

Simon has over 10 years of experience in the drug development process, including pre-clinical pharmacology/toxicology, Phase I (including first-in-human) pharmacology/PK studies and investigator-led Phase II/Phase III trials. In addition to undergraduate and postgraduate qualifications in pharmacology, Simon also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine (Royal College of Physicians). 

Simon has extensive practical experience and scientific knowledge of the design, management and reporting of clinical development projects.  He was a contributor to the revised 2017 EMA First-in-Human guidance and is Chair of the EUCROF Early Phase Research Working Group.

Who Should Attend?

This webinar is for biotechnology companies who have compounds in the preclinical stage preparing to enter clinical operations.

Relevant job functions include:

  • CEO
  • CMO
  • CSO
  • VPs/Directors of Clinical Operations
  • VPs/Director of Clinical Pharmacology
  • VPs/Directors of Translational Medicine

Xtalks Partners

Simbec-Orion

Orion Clinical is the full-service clinical development division of Simbec-Orion Group.

Founded 20 years ago as a full service CRO we have expanded, through consistent delivery of studies in complex areas. Our operations are based in the United Kingdom, France, USA, Germany and Italy. We have operational staff across mainland Europe (Western, Eastern & Central) and throughout North America.

With over 20 years of experience in the delivery and conduct of oncology clinical trials, including rare & orphan and paediatric studies, we use our skills elegantly to design, execute and deliver our clients’ clinical development needs.

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