Speaker

Sep 29-29, 2021    London, UK

Webinar on

Bioavailability and Bioequivalence

Geert C Mudde
11:40 AM-12:00 PM

Geert C Mudde

managing director for S-TARget therapeutics Vienna, Austria

Title: Forensic Toxicology Laboratory Guidelines

Abstract:

Laboratory and Personnel: means and equipment for toxicological analysis should meet an acceptable scientific standard. Laboratory procedures must ensure the safe handling of any hazards (toxic, biological samples, and prohibit), access for the laboratory, must be for only authorized persons (director, quality manger analysts, consultant, evidence officer,..) and an adequate detection, and quantification must be performed for all substances under laboratory scope. Laboratory personnel (director, consultant, analysts) are sufficient trained and experienced to conduct their work and maintained the competency of laboratory. Sample and Receiving: Proper and sufficient samples must be taken to get accurate results. Laboratory director or his designee should develop and provide detailed guidelines and instructions to all agencies which the laboratory serve. Specimens received by the laboratory must identified and store in a good and secure place such that the integrity of the specimens is safeguarded. Acceptable written standard operating procedures (SOP) should be followed. Practical work: All samples and extracts must be labeled in a good manner to ensure the integrity of the analytical results. Chain of custody (COC) very important to document the path of the specimen through the laboratory. Methods and procedures in (SOP) manual must be validated and written in clear manner ,and contain sufficient information, that the analysts can follow them. All documents should be approved by laboratory director or his designee. Any changes in documents (method or procedure) must be clearly documented, stating the reasons for the changes, must be approved also by the director of the laboratory or his designee. Detection by screening techniques (ex: Immunoassay) can apply first, after that confirmatory techniques (Chromatographic Techniques) with proper validated methods, quantitation, and calibration must apply for interpretation of the results. Review and Documentation of The Results: It’s very important for the laboratory to have their own internal quality program, and depending on the type of the laboratory analysis the laboratory should participate in external quality assurance and proficiency testing programs. All analysis results must be documented. This record should include all information necessary to identify the case (name of agency, name of accused person, case number, description, and number of exhibits,…). Review of the results should be run in two steps technical and administrative. The final report must answer all the requesting from all agencies or parties (Request Form) which the laboratory serve. Reference TIAFT-Bulletin XXXI Number 4 p. 23-26

Biography:

Dr. Geert C. Mudde received a Ph.D. in immunology from the University of Utrecht in 1985 and started his international professional career at the Swiss Institute for Asthma and Allergy Research in Davos in 1989. In 1992 he joined the pharmaceutical/biotech industry, where he held several senior management positions at the Novartis Research Institute in Vienna, Austria, the Parke Davis Research Institute in Fresnes, France, Ingenium Pharmaceuticals, Martinsried, Germany, and at igeneon AG, Vienna, Austria. Finally, in 2006, while joining Baxter BioScience in Vienna as interim manager, Dr. Mudde co-founded the biotech company f-star Biotechnology, where he served as “Chief Scientific Officer” from 2007 to 2009. In 2009, together with Christof Langer, he started to develop the S-TIR™ technology platform for human-specific therapeutic vaccines which led to the foundation of S-TARget therapeutics GmbH in 2010. Since then he serves as CSO and managing director for S-TARget therapeutics as well as for the S-TIR™ technology spin-off companies OncoQR ML GmbH and TYG oncology Ltd., which were both founded in 2013