Webinar Topic
Staying Safe on the Way to Innovative Therapeutic Options - Phase I Trials in Research Clinics
Webinar Date & Time
17 May 2021 from 3:00 PM to 4:30 PM (CEST)
Webinar Overview
In the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed.
In drug development the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials.
To ensure utmost safety a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol as well as for the translation into practical conduct for executing infrastructures in specialized Phase I research clinics.
The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials.
Since this law does not distinguish between the different phases of drug development starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”.
This webinar will help to understand more about the risks and benefits of early-stage clinical trials conducted in specialized Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials:
- safety management plan
- adequate personal resources
- adequate locations/wards
- adequate technical equipment
- processes for management of emergencies
- adequate conditions for PK sample, collection, handling and processing.
Presenters
Dr Angela Bischoff
Dr. Angela Bischoff, PhD
Director Clinical Operations
ARENSIA Exploratory Medicine
Dr. Angela Bischoff, PhD has been part of ARENSIA Exploratory Medicine since its foundation and is the Director of Clinical Operations. Over the last 20 years Angela has worked in project management and quality assurance for Phase I/II clinical trials involving both, healthy volunteers and patients. Her experience includes pharmacological and logistic overview of more than 500 early stage development clinical trials.
Dr. Eugenia Prohin
Dr. Eugenia Prohin, MsC
Manager Clinical Operations
ARENSIA Exploratory Medicine
Dr. Eugenia Prohin, psychiatrist by training, has been lead investigator in neuroscience research at ARENSIA Exploratory Medicine since 2012 and Manager International Clinical Operations since 2018. Dr. Prohin was directly involved into the development of corporate strategy of continuous clinical operations during the COVID-19 pandemic. Dr. Prohin performs clinical overview of early phase trials in 7 ARENSIA research clinics in Eastern Europe.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
25 April 2021
How to register?
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Confirmation
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