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QA Reg: Going from drug discovery to Preclinical toxicology and First time in Man (and regulatory requirements for medical devices part 1)

12 oktober
08:00 - 10:00

Medical Growth House - Forskningsparken

CiToxLAB from Denmark is giving an introductory talk on two very essential topics in the regulatory area: Going from drug discovery to Preclinical toxicology and First time in Man and Regulatory requirements for medical devices

Going from drug discovery to Preclinical toxicology and First time in Man:

When running a research project often scientists can stumble over discoveries that could be a new medical treatment. Taking an idea to making a drug that can be tested in humans is a long, complex and expensive process. In this talk we will highlight some requirements, needs and good advice when developing your drugs whatever it is a classical small molecule drug or a biopharmaceutical drug.

Regulatory requirements for medical devices:

All medical devices must be tested and approved according to the international standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1:

Evaluation and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body. According to the standard, an assessment for biological effects from the exposure of a medical device or material to human body can include testing such as cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity, subchronic toxicity, genotoxicity, implantation and haemocompatibility, etc.

We will go through some of these requirements and exemplify the type of biological testing needed in order to get your medical devices approved.

Påmelding

Speakers

Anita Moe Larsen

Head of Communication - Norway Health Tech

aml@norwayhealthtech.com

Kim Dekermendjian

Business Development & Key Account Manager - CiToxLAB Scantox

KDE@dk.citoxlab.com

Andrew Makin

Scientific Director and Director of Business Development and Sale - CiToxLAB Scantox

am@dk.citoxlab.com