Pre Conference Satellite Event

IUPAC/CITAC Workshop on
Quality of Test Results for Conformity Assessment
of a Chemical Composition

What is Good and What is Bad?

January 21, 2019
Kfar Maccabiah, Ramat Gan

The main goal of the workshop is discussion of the quality parameters of test (chemical analytical) results in pharmaceutical industry, environmental analysis, metallurgy and other fields, necessary for conformity assessment of a material or object. This discussion will include the following topics:

  • use of measurement uncertainty as a parameter of quality of test results
  • evaluation of correlation of test results of concentrations of different components as another quality parameter of the results
  • influence of measurement uncertainty and correlation of the test results on probabilities of false decisions on conformity of the material or object
  • ways of minimization of measurement uncertainty to its target value and quality improvement

The members of the International Advisory Committee:

Chairman:
Dr. Ilya Kuselman Independent Consultant on Metrology, Israel
Members:
Dr. Francesca Pennecchi Istituto Nazionale di Ricerca Metrologica, Italy
Prof. Ricardo J.N. Bettencourt da Silva Faculdade de Ciências da Universidade de Lisboa, Portugal
Em. Prof. D. Brynn Hibbert School of Chemistry, University of New South Wales, Sydney, Australia

Registration fees for foreign participants are as follows:

Category Early registration
until Dec. 19, 2018
Registration from
Dec. 20, 2018 to Jan. 20, 2019
Regular participant 290 USD
320 USD
Associate participant* 260 USD 290 USD
Participant from a developing country 200 USD 230 USD
Student 145 USD 175 USD

*Associate participants are Members, Affiliates and Fellows of IUPAC and CITAC


Registration fees for Israeli participants are as follows (Not including VAT):

Category Early registration
until Dec. 19, 2018
Registration from
Dec. 20, 2018 to Jan. 20, 2019
Regular participant 1220 NIS 1350 NIS
Student 535 NIS 700 NIS



Program

Duration

Topic (linked to the abstract) Speaker (linked to the BIO)
8:00 - 9:00

Registration

9:00 - 9:05 Opening remarks Dr. Ilya Kuselman
Chair of the Workshop International Advisory Committee, Israel
9:05 - 9:15 IUPAC welcoming introduction Prof. Érico M.M. Flores
Vice-President of the IUPAC Analytical Chemistry Division, Universidade Federal de Santa Maria (UFSM), Santa Maria, Brazil
9:15 - 9:25 CITAC mission and guidelines Dr. Michela Sega
Chair of the Cooperation on International Traceability in Analytical Chemistry (CITAC), Istituto Nazionale di Ricerca Metrologica (INRIM), Italy
9:25 - 10:10 Plenary lecture:
Evaluating and using big data in chemistry

Em. Prof. D. Brynn Hibbert
School of Chemistry, University of New South
Wales (UNSW), Sydney, Australia
10:10-10:35 ILAC – a mechanism to provide quality test results Mr. Steve Sidney
Chair of the Laboratory Committee at the International Laboratory Accreditation Cooperation (ILAC), NLA, South Africa
10:35-11:00 Conformity assessment standards
Dr. Ilya Kuselman
Independent Consultant on Metrology, Israel
11:00-11:20 Coffee break
11:20-11:45 Risks of false decisions in conformity assessment Dr. Francesca R. Pennecchi
Istituto Nazionale di Ricerca Metrologica (INRIM), Italy
11:45-12:10 Setting data requirements Prof. Ricardo J.N.B. da Silva
Faculdade de Ciências da Universidade de Lisboa,
Portugal
12:10-13:00 Round-table discussion:
Which parameters of test results quality should be taken into account for characterization of a product before its way to the market?
Moderator: Dr. Michela Sega
INRIM, Italy
13:00-14:00 Lunch
14:00-14:25 TBA  
14:25-14:50

Risks and new possibilities in sample preparation for further halogens determination in organic matrices

Prof. Érico M.M. Flores
Universidade Federal de Santa Maria (UFSM), Santa Maria, Brazil
14:50-15:15 Detection and identification of drugs – The challenges of meeting scientific and legislative standards Dr. Simcha Shimron
Division of Identification and Forensic Science (DIFS), Israeli Police, Israel
15:15-15:35 Coffee break
15:35-16:00 Challenges in determination of active pharmaceutical ingredients and their stability in Cannabis based drug products Dr. Orna Dreazen
Nextar Chempharma Solutions Ltd, Israel
16:00-16:25 Reference materials for your tasks and applications Dr. Markus Obkircher
Sigma-Aldrich Production GmbH, Buchs, Switzerland
16:25-17:00 Round-table discussion: Which test results are good for conformity assessment, and which are bad?
Moderator: Dr. Raphy Bar
BR Consulting, Israel

 

Lecturers

Ilya Kuselman
Ilya Kuselman has received his Ph.D. in inorganic chemistry from Kalinin State University, and D.Sc. in analytical chemistry – from R&D Institute for Rare Metal Industry, Moscow, Russia. Since 1971 to 1990 Ilya has been researcher and then Head of Metrology in Chemistry Division of All-Union R&D Institute of Non-ferrous Secondary Metals, Donetsk, Ukraine, USSR. Since 1991 to 2014 he was a co-worker and further Director of the National Physical Laboratory of Israel. Now Ilya is Independent Consultant on Metrology. He has published above 200 papers on metrology and quality in analytical chemistry. Ilya is a member of CITAC, ISO/REMCO and IUPAC Analytical Chemistry Division.
He is also Chair of the IUPAC Interdivisional Working Party on Harmonization of Metrology and Quality Guidelines.


Francesca Pennecchi
Dr. Francesca Romana Pennecchi, PhD in “Metrology: measurement science and technique”, is a researcher at the Istituto Nazionale di Ricerca Metrologica (INRIM, Italy). Her activity is focused on the development of mathematical and statistical methods for evaluating measurement uncertainty, analysing interlaboratory comparisons data and modelling risk of false decisions in conformity assessment. She is committee member of CITAC, Eurachem/CITAC WG on Measurement Uncertainty and Traceability, ISO/TC 69/SC 6/WG 7 on Statistical methods to support measurement uncertainty evaluation, and participated into several IUPAC, EMRP, EMPIR Projects. She is co-author of more than 50 papers published on JCR journals, with h-index 12.


Ricardo da Silva
Prof. Ricardo J.N. Bettencourt da Silva after working in public and private laboratories as analyst and consultant for 15 years, started a research and teaching career at the Faculty of Sciences of the University of Lisbon. His research interests are Metrology and Examinology in chemistry, the sciences of measurements and qualitative analysis in chemistry, respectively. He collaborates in teaching at Master Courses of consortiums of various Universities. Since 2002, collaborates regularly with the Portuguese Accreditation Body, as technical assessor. Ricardo is currently Secretary of CITAC (www.citac.cc), member of the executive committee of Eurachem and chair of the Eurachem working group on Qualitative Analysis (www.eurachem.org). (website: http://webpages.fc.ul.pt/~rjsilva/)


Em. Prof. D. Brynn Hibbert occupied the Chair of Analytical Chemistry at the University of New South Wales since arriving from England in 1987 until his retirement in 2013.
His research interests are in metrology and statistics in chemistry, ionic liquids and electroanalytical chemistry, but he also does a sideline in expert opinion, scientific fraud and presenting science to the public.
More recently he has become a go-to expert witness in matters of drugs (of abuse, and sports). He is Past President of the Royal Society of New South Wales.
Brynn has published around 250 papers, 5 books and 3 patents.


Dr. Michela Sega is a chemists and holds a PhD in Chemical Sciences, from the University of Torino, Italy. She is a permanent researcher at the Italian Metrology Institute “Istituto Nazionale di Ricerca Metrologica – INRIM”. She leads the laboratory of Primary gravimetric gas mixtures and organic analysis. Her main research activities are related to metrology in chemistry, focused on gas analysis and organic analysis.
She is currently the chairperson of CITAC and of the IMEKO Technical Committee TC8 “Traceability in metrology”. She is a member of Eurachem and had been the chairperson of the EURAMET Technical Committee on Metrology in Chemistry from 2011 to 2015.
She is co-author of about 30 publications on international and national journals.

Dr. Raphael Bar (Ph.D. in Chemistry 1984) is presently a pharmaceutical consultant for the Pharma and bio-Pharma industries. He is consulting various companies and provides development and analytical support to investigational, generic, new drugs as well as combination device-drug products. After a postdoc in biochemical engineering at UVA (Va, USA), he joined the Hebrew University as a Lecturer in the Biotechnology program. He then joined the pharmaceutical industry to manage analytical R&D and QC laboratories. Bar has been providing training courses to the pharma industry for more than ten years on analytical method development and validation, GMP-related issues and statistical evaluation of laboratory data including drug stability data and environmental monitoring data. He is a regular Speaker at the European compliance Academy (ECA). He has been a member of the scientific advisory board of global PDA (USA) during the years 2009 – 2015. He is past president and present member of Israel PDA Chapter.

Dr. Markus Obkircher is the head of Merck’s Reference Materials Research & Development division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials. Prior to this position he was R&D Manager in Buchs, Switzerland, with a strong focus on synthesis, characterization and certification of reference materials. He joined Merck / Sigma-Aldrich five years ago after heading the development unit for a custom API manufacturer. Before that he completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, Switzerland.

Mr. Steve Sidney graduated from the University of Johannesburg. Initially he worked for Fluke South Africa, and was subsequently appointed the Managing Director of Altech Instruments in the mid 80’s. Since 1997 Steve started a management-consulting practice.
He has been involved in laboratory as well as accreditation issues. Steve was appointed a Board Member of both the National Laboratory Association – South Africa (NLA-SA) as well as SANAS in the early 90’s, and is currently the NLA director.
Steve is Chair of ILAC Laboratory Committee and a member of Accreditation Issues Committee, a member of JCGM WG1at BIPM, and Co-convenor of ISO WG44 reviewing ISO 17025.

Prof. Érico M. M. Flores has a permanent position at Federal University of Santa Maria/Brazil and is Scientific Director of Rio Grande do Sul State Research Foundation. He has experience in development of methods for sample preparation, speciation analysis and quality control using atomic spectrometry, published more than 300 papers, a book and book chapters. Érico has developed a new system of microwave induced combustion, commercialized in a number of countries. He is a titular member of Deliberative Council of Brazilian Pharmacopoea, editor or member of Editorial Board of some scientific journals and Vice-president of Analytical Chemistry Division of IUPAC.

Dr. Orna Dreazen holds a Ph.D. in Biochemistry from the Weizmann Institute of Science.
Dr. Dreazen served as the Director of the National Public Health Laboratories and the Director of the National Laboratory Accreditation Authority. She was also a member of the ILAC executive committee as well as ILAC representative to ISO, BIPM and WHO.
Currently she is the CEO and Chairperson of Nextar Chempharma solutions Ltd. engaged in the development of innovative medical devices and drug products.


Dr. Simcha Shimron holds Ph.D in Chemistry from the Hebrew University in Jerusalem. Since graduating he has been working as an expert in drug identification at the National Drugs Laboratory of the Division of Identification and Forensic Science (DIFS), Israeli Police, responsible also for quality assurance in the Lab.

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