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Previous Technical OMCL Falsified Medicines Training Sessions

14th and 15th Technical OMCL Falsified Medicines Training

16-17 October and 20-21 November 2018, Prague, Czech Republic

On 16-17 October 2018 and 20-21 November 2018, two technical training sessions for OMCLs on the testing of falsified and illegal medicines took place on the premises of the National Health Institute in Prague, the location of the Czech OMCL for human medicines (SÚKL). The sessions were the 14th and 15th in a series of hands-on training programmes for OMCLs co-organised by members of the GEON and the EDQM.

The training programme was split into two separate sessions due to the large number of applicants for the October course. The objective of the 2-day training course was to present a general approach on how the analysis of falsified, unknown products could be performed in small OMCLs.

Twenty OMCL trainees from 18 countries followed the two courses, which consisted each of a general introductory part, theoretical lectures and practical sessions in two small groups running in parallel.

The following methodologies were presented:

- Liquid Chromatography – Mass Spectrometry (TOF)
- Infrared and Raman Spectroscopy

Trainees were also given an overview of the general strategy of the human Czech OMCL for testing suspicious unknown samples, detailed in an internal SOP, and had the opportunity to discuss practical matters during a laboratory tour with staff members. Towards the end of the training sessions, time was allocated for discussion, allowing the trainees to exchange experience with peers and provide feedback to the organisers.

Hands-on training for OMCLs on the testing of falsified medicines has become a regular offering of the GEON and will be continued in 2019 due to great interest from Network members and positive feedback received from participants.


12th and 13th Technical OMCL Falsified Medicines Training

3-4 May and 11-12 October 2017, Brussels, BE

On 3 and 4 May 2017 and 11 and 12 October 2017, two technical training sessions for OMCLs on the testing of falsified and illegal medicines took place on the premises of the Scientific Institute of Public Health in Brussels, the location of the Belgian OMCL for human medicines. The sessions were the 12th and 13th in a series of hands-on training programmes for OMCLs co-organised by members of the OMCL Network and the EDQM. For the first time, chemometric methods and their practical implication for OMCLs were the focus of the training.

Twenty OMCL staff members from 16 countries attended the two sessions aimed at providing an introduction to chemometric analysis methodology and presenting potential future fields of activity at OMCLs. The training started with a general introductory session and theoretical lectures and continued with practical sessions, including a demonstration of data handling and analysis using a commercially available software package.

The trainees were also given an overview of the general strategy of the Belgian OMCL for testing suspicious unknown samples and had the opportunity to discuss practical matters during a lab tour with staff members. Towards the end of the training sessions, time was allocated for discussion, allowing the trainees to exchange experience with peers and provide feedback to the organisers.

Hands-on training for OMCLs on the testing of falsified medicines has become a routine offering of the GEON and will be continued in 2018 due to great interest from Network members and positive feedback received from participants.


10th and 11th Technical OMCL Falsified Medicines Training

12-13 October 2016 and 8-9 February 2017, Uppsala, Sweden

The 10th and 11th technical training sessions for OMCLs on the testing of falsified and illegal medicines took place on 12 and 13 October 2017 and 8 and 9 February 2017, respectively, at the premises of the Medical Products Agency (MPA) in Uppsala, Sweden. Both sessions were co-organised by the Swedish OMCL and the EDQM.

Nineteen participants from 19 member states followed the two courses, which consisted of a general introduction, theoretical lectures, parallel practical sessions in small groups in the lab, and common data analysis. The training focused on the following techniques:

  • LC-QTOF-MS/MS
  • NMR spectroscopy

The approach of the MPA lab to the analysis of unknown suspicious samples, using both techniques alone or in combination to identify and quantify active ingredients in illegal medicines, was presented in detail. Particular attention was given to sample preparation and the interpretation of spectra.

The training gave the participants the opportunity to follow, in the laboratory, the testing of two authentic samples from the illegal market and to exchange experience and discuss possible testing strategies with peers. The hands-on training for OMCLs on the testing of falsified medicines has become a routine programme of the GEON and will be continued due to the great interest from Network members and the positive feedback received from those who have followed the training sessions so far.


9th Technical OMCL Falsified Medicines Training

31 May - 1 June 2016, Bilthoven, NL

The 9th tailor-made hands-on training for OMCLs on the testing of falsified and illegal medicines took place on 31 May and 1 June 2016 at the premises of the National Institute for Public Health and the Environment (RIVM) in Bilthoven, the Netherlands, and was co-organised by the Dutch OMCL and the EDQM. The main topics of this training session were vibrational spectroscopy, LC-MS and basic chemometric methodologies. This training session was the second to be organised at the premises of RIVM since 2013, with an enlarged scope and extended schedule.

Eight trainees from 8 member states followed the course, which consisted of a general introductory part, theoretical lectures and four parallel practical sessions in small groups where the following techniques were addressed:

- Near Infrared Spectroscopy (NIR)/Middle Infrared Spectroscopy (MIR)
- Raman Spectroscopy
- Handheld IR/Raman
- LC-MS

The training gave the participants the opportunity to follow, in the laboratory, the testing and comparison of authorised and falsified samples of medicines from the field and to exchange experience and discuss sample preparation, test performance and the interpretation of test results with peers. The hands-on training programme for OMCLs on the testing of falsified medicines will be continued due to the great interest from Network members and the positive feedback received from the trainees who have participated so far in the training sessions.


7th and 8th Technical OMCL Falsified Medicines Training

18-19 November 2015 and 24-25 February 2016, Berne, Switzerland

The 7th and 8th technical training sessions for OMCLs, which were the first hands-on training programmes on the analysis of biological falsified and illegal medicines, took place on 18 and 19 November 2015 and 24 and 25 February 2016 at the premises of the Swiss OMCL for human medicines in Berne. Both events were co-organised by the OMCL at SWISSMEDIC and the EDQM. The split into two separate sessions became necessary due to the large number of applicants who had registered for the November course.

The objective of the 2-day training course was to present the approach taken at the Swiss OMCL when analysing unknown biological samples. The basis of the training was a real “biological falsified medicine” case the OMCL had worked on. Eighteen trainees from 15 member states followed the two courses which consisted each of a general introductory part, theoretical lectures and practical sessions in small groups, allowing sufficient time for discussion.

During the training, top-down and bottom-up proteomics applying in-house methods based on coupled Mass spectrometry techniques (LC-MS QTOF and LC-MS QTRAP) were introduced, with particular focus on sample preparation and data evaluation employing suitable IT tools. The training provided the participants with an insight into the testing strategies of a peer OMCL on a concrete example of a biological falsified medicine and allowed them to exchange experience with colleagues from the same professional field about the different analysis steps.

Other members of the GEON have already indicated their interest in hosting similar training courses in the near future and currently new programmes are being developed with the help of the Falsified/Illegal Medicines Working Group.


5th and 6th Technical OMCL Falsified Medicines Training

5-6 November 2014 and 3-4 March 2015, Montpellier, France

Two additional hands-on training sessions for OMCLs on the testing of falsified and illegal medicines took place on 5 and 6 November 2014 and 3 and 4 March 2015 at the premises of ANSM in Montpellier-Vendargues, France, and were co-organised by the OMCL at the French National Agency for Medicines and Health Products Safety and the EDQM.

The training programme was split into two separate sessions due to the large number of applicants for the November course. The objective of the 2-day training course was to present a general approach for the analysis of falsified, unknown products.

Seventeen trainees from 17 member states followed the two courses which consisted each of a general introductory part, theoretical lectures and practical sessions in small groups, allowing sufficient time for discussion.

The following methodologies were introduced:
- X-Ray Fluorescence Spectrometry ICP-MS[1]
- Raman and NIR Image Analysis Impurity profiles/API fingerprinting

The training provided the participants with an insight into the testing strategies of a peer OMCL with respect to unknown samples suspected to be falsified, and allowed them to exchange experience with colleagues from the same professional field about the different analysis steps from sample preparation to interpretation of test results, including the application of chemometric methods. Further technical falsified medicines training programmes for OMCLs are currently in preparation.

[1] November session only


3rd and 4th Technical OMCL Falsified Medicines Training

5-6 December 2013 and 30-31 January 2014, Vienna (Austria)

Two new tailor-made hands-on training sessions for OMCLs on the testing of falsified and illegal medicines took place on 5 and 6 December 2013 and 30 and 31 January 2014 at the premises of AGES in Vienna, Austria, and were co-organised by the Austrian OMCL and the EDQM. In view of the large number of applicants the training was split into two separate sessions.

The main topics of the training were preparation and analytical monitoring of suspect samples by GC/MS and UPLC/Q-TOF-MS. Twenty-four trainees followed the two courses which consisted each of a general introductory part, theoretical lectures and two parallel practical sessions in small groups where the following techniques were introduced:

- Isolation by preparative HPLC
- + GC/MS Isolation by TLC
- + UPLC/Q-TOF-MS

The training gave the participants the opportunity to follow the preparation and testing of samples of falsified medicines in the laboratory and to exchange experience with peers about sample preparation, test performance and the interpretation of test results. Further technical falsified medicines training programmes for OMCLs with a focus on other techniques and different analytical strategies are currently in preparation.


2nd Technical OMCL Falsified Medicines Training

17-18 June 2013, Bilthoven (The Netherlands)

The second tailor-made hands-on training session for OMCLs on the testing of falsified and illegal medicines took place on 17 and 18 June 2013 at the premises of the National Institute for Public Health and the Environment (RIVM) in Bilthoven, the Netherlands, and was co-organised by the Dutch OMCL and the EDQM. The main topics of this training session were vibrational spectroscopy and chemometrics.

Twelve trainees from 11 member states followed the course which consisted of a general introductory part, theoretical lectures and two parallel practical sessions in small groups where the following techniques were introduced:

- Near Infrared Spectroscopy (NIR)
- Raman Spectroscopy

The training gave the participants the opportunity to follow the testing and comparison of authorised and falsified samples of medicines in the laboratory and to exchange experience with peers about sample preparation, test performance and the interpretation of test results. Further technical falsified medicines training programmes for OMCLs with a focus on other techniques are currently in preparation.


1st Technical OMCL Falsified Medicines Training

4-5 October 2012, Warsaw (Poland)

The first hands-on training for OMCLs on the testing of falsified and illegal medicines took place on 4 and 5 October 2012 at the premises of the Official Medicines Control Laboratory at the Polish National Medicines Institute in Warsaw, Poland. This training was co-organised by the Polish OMCL and the EDQM. A broad range of techniques used for the identification of unknown samples suspected to be falsified were introduced to the participants. Twenty trainees from 17 member states followed the course which consisted of a general introductory part, theoretical lectures and five parallel practical sessions in small groups.

The following techniques were the focus of the training:
- LC-MS/MS-Time-of-Flight (TOF)
- LC-CAD (Charged Aerosol Detection)
- XRPD (X-ray Powder Diffractometry)
- NMR Psychoactive plants identification

The training gave the participants the opportunity to follow the testing of falsified and illegal samples of medicines in the laboratory and to exchange experience with peers about sample preparation, test performance and the interpretation of test results. After this successful first technical falsified medicines training for OMCLs it was agreed within the Network to continue with the programme. Further training sessions will follow in the future with a focus on other techniques.

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