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Industry - Regulator Dialogue: Tailor-made Regulatory Guidance for Non-clinical to Clinical Development
Session Chair(s)
Jeroen Bos, PharmD
Global TA lead Regulatory Affairs
Novartis Pharma AG, Switzerland
Jan Willem van der Laan, PhD
Senior Assessor Pharmacology and Toxicology
Medicines Evaluation Board, Netherlands
i) First in human programs Since the implementation of the new revised EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, there has been an interest as to the response by the Pharmaceutical Industry. Would the guideline be interpreted as too conservative and force companies to conduct FIH studies in non-EU geographies? EFPIA conducted a survey among 12 member companies with 54 FIH studies. ii) Programs in Severe Diseases/Conditions For a small number of severely debilitating or life-threatening (SDLT) diseases/conditions, regional guidances exist encouraging the use of “ICH S9-like” approaches. A lack of incentives for drug developers to engage into costly development may lead to unclear prospective. This session item will address a harmonized and focused approach on development options for SDLT indications to reduce resources to start early clinical development, to bring innovative medicines to patients faster.
Speaker(s)
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Charles Benson, MD, PhD
Eli Lilly and Company, United States
Senior Director Clinical Phamacology
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Beatriz Silva Lima, PharmD, PhD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Ann Marie Janson Lang
and Coordination Group (under Heads of Medicines Agencies), Sweden
Medical Products Agency (MPA) Co-Chair, Clinical Trials Facilitation
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Peter Pertel, MD, MPH, FACP
Novartis Institutes for BioMedical Research, United States
Global Head of Translational Medicine for Respiratory and Infectious Diseases
How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Andreas Hartmann, PhD
Novartis Pharma, Switzerland
Executive Director
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Ulla Wändel Liminga, DrMed, MS, RPh
Medical Products Agency (MPA), Sweden
Scientific Director Pharmacology/Toxicology
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Joseph Brady, PhD
Pfizer, United States
Senior Director
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Salah-Dine Chibout
Novartis Pharma AG, Switzerland
Global Head Discovery & Investigative Safety/Preclinical Safety Therapeutic Area
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Roy Forster, PhD, MA
Experimental Pharmacology and Oncology Berlin-Buch GmbH, Germany
Expert, Nonclinical Development
Efforts to accelerate drug development and patient access to drug candidates treating severely debilitating or life-threatening (SDLT) conditions
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
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