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European Pharmacopoeia Training Resources

 

In line with its commitment to providing clear and timely insight into its work and activities, the EDQM makes the resources of its  training sessions publicly available for the benefit of those stakeholders who could not attend in person.

Events by topics


Veterinary medicinal products

Training on the Management of Extraneous Agents in IVMPs - Setting the Scene - Part 1 (Webinar recorded on 1 April 2020)

Language: English. Duration: 2 hours, 30 minutes.

The approach to extraneous agent testing in IVMPs has recently been updated and manufacturers of these products are required to comply with new standards from 1 July 2020. This webinar covers topics such as a summary of the revised Ph. Eur. requirements for extraneous agent testing, what has changed and why, with a particular focus on risk management and with concrete examples on how to apply the new approach. Includes discussions and Q&A sessions with the speakers and Ph. Eur. Experts.


Training on the Management of Extraneous Agents in IVMPs - European Regulatory Landscape - Part 2 (Webinar recorded on 1 April 2020)

Language: English. Duration: 1 hour, 45 minutes.

The approach to extraneous agent testing in IVMPs has recently been updated and manufacturers of these products are required to comply with new standards from 1 July 2020. This webinar focusses on the European regulatory landscape. Participants will learn from representatives of regulatory authorities about the impact of the new approach on existing products and on best ways to apply the new approach. Includes discussions and a Q&A session with the speakers and Ph. Eur. experts.


The European Pharmacopoeia

European Pharmacopoeia Training Webinars, 7-8 July 2020, online

NEW: Ph. Eur.  Training Webinar Session 1: General Concepts & Methods (Webinar recorded on 07 July 2020)
Language: English  Duration: 2 hours, 20 minutes  

 

NEW: Ph. Eur. Training Webinar Session 2: Ph. Eur. Monographs (Webinar recorded on 07 July 2020)
Language: English  Duration: 2 hours, 44 minutes  

 

NEW: Ph. Eur. Training Webinar Session 3: Ph. Eur. Reference Standards & Databases (Webinar recorded on 08 July 2020)
Language: English  Duration: 2 hours, 8 minutes  

 

NEW: Ph. Eur. Training Webinar Session 4: Certificate of Suitability (CEP) Procedure (Webinar recorded on 08 July 2020)
Language: English  Duration: 3 hours, 31 minutes  


European Pharmacopoeia workshop, 10-11 September 2019, Iselin, New Jersey, USA

    Access the presentations (PDF format)

    EDQM and the European Pharmacopoeia: role in the European regulatory network by Susanne Keitel

    General Concepts in the European Pharmacopoeia by Cathie Vielle

    Specific monographs on substances for pharmaceutical use by Ulrich Rose

    Use of Reference Standards in specific monographs by Jochen Pauwels

    Impurity Control in the European Pharmacopoeia by Ulrich Rose

    Use of Reference Standards for impurity control by Jochen Pauwels

    Specific Monographs on Finished Products (containing chemically defined APIs) by Ulrich Rose

    Use of Reference Standards for Finished Products by Jochen Pauwels

    Role of RS in monographs for recombinant biotherapeutics - Peptide mapping and glycan analysis by Jochen Pauwels 

    The Certification of Suitability (CEP) Procedure by Susanne Keitel

    Nitrosamine impurities in sartans: the EDQM holistic approach to address the issue by Susanne Keitel

    New and revised Ph. Eur. General Chapters by Ulrich Rose

    The Ph. Eur. enabling QbD and Continuous Manufacturing by Cathie Vielle

    How to participate in the Elaboration of the European Pharmacopoeia by Mihaela Buda

    International Harmonisation and Collaboration Initiatives by Cathie Vielle

    Find your way in Pharmeuropa - Knowledge database & Ph. Eur. Online: Useful hints and other practicalities by Pierre Leveau

    European Pharmacopoeia Reference Standards: Establishment by Jochen Pauwels

    European Pharmacopoeia Reference Standards: Handling, dispatch, where to find useful information and other practicalities by Pierre Leveau

     


    Chemically-defined substances

    Chinese and European Pharmacopoeia Joint Workshop: What’s New in the field of excipients in China, 18 September 2018, Strasbourg, France

    Access the recorded presentations (video format)

     

    Timecodes:

    0:09 Zhang Wei - Chinese Pharmacopoeia ChP
    1:29 Jiasheng Tu - Guidance on Pharmaceutical Excipient Suitability Studies with ChP
    2:01 Xiaoxu Hong - Establishment SSPE in ChP
    4:26 Xiaoxu Hong - Risks, classifying, technical requirements Pharmaceutical excipients
    4:58 Jiasheng Tu  - Submission Requirements for Registration application dossiers
    5:26 Jiasheng Tu - Regulation Pharmaceutical excipients in China
    5:42 Xiaoxu Hong - Considerations for Production & QC for animal derived excipients
    7:40 Susanne Keitel - Pharmacopoeial Convergence and Harmonisation

     

    EDQM Training session - Chemically-defined substances 24-25 May 2018, Zagreb, Croatia

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    Elemental Impurities

    Elemental Impurities (Webinar recorded on 16 May 2017)
    Language: English - Duration: 1 hour, 15 minutes

    The ICH Q3D guideline represents a change of paradigm in the control of elemental impurities in medicinal products. This webinar covers how the implementation of ICH Q3D impacts on Ph. Eur. texts and on the assessment of CEP applications. The recording includes the Q&A session after the presentations.

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    Biologicals

     

    EDQM Training Session - Biologicals, 4-5 February 2020

     Access the presentations (PDF format)
     

     

    European Pharmacopoeia training session on Biologicals, 7-8 February 2017, Strasbourg, France

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    Joint EDQM-EMA Session on Biosimilars 8 February 2017, Strasbourg, France

    Access the recorded presentations (video format)

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    Biologicals in the twenty-PhEur-st Century (Webinar recorded on 19 March 2015)
    Language: English - Duration: 1 hour, 20 minutes

    This webinar provides an overview of the main Ph. Eur. texts dealing with biologicals, with a specific focus on biotech products. It also presents the flexibility provided by the Ph. Eur. including examples of QbD approaches for biologicals and the role of the Ph. Eur. within the biosimilar context.

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    Microbiology

    International Microbiology Symposium 10-11 October 2017, Strasbourg, France

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    Raw Materials for the Production of Cell-based and Gene Therapy Medicinal Products

    Raw Materials for the Production of Cell-based and Gene Therapy Medicinal Products (Webinar recorded on 9 November 2017)
    Language: English - Duration: 1 hour, 30 minutes.

    The aim of this webinar is to explain the context of the elaboration of the new European Pharmacopoeia (Ph. Eur.) general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products and its scope. The first part of the webinar gives an introduction to the Ph. Eur. and its place within the EU regulatory network. The second part is dedicated to the general chapter 5.2.12 and provides information on the context of its elaboration followed by an overview of the chapter and the class of raw materials of biological origin covered. 

    Register for FREE and receive the webinar recording

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    Homoeopathic products

    European Pharmacopoeia Training Homoeopathic Products, 6 December 2016, Strasbourg, France

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    Finished products monographs containing chemically defined substances in the Ph. Eur.

    Finished products monographs containing chemically defined substances in the Ph. Eur. (Webinar recorded 4 February 2016)

    Language: English. Duration: 50 minutes.

    This webinar provides a general overview of the principles for finished product monographs with chemically defined active substances within the Ph. Eur., the content of these monographs and an update on the work programme. The monograph on Sitagliptin tablets (2927) is also covered.

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    Glass Containers for Pharmaceutical Use (General chapter 3.2.1)

    Webinar on Glass Containers for Pharmaceutical Use (General chapter 3.2.1) (recorded 10 December 2015)
    Language: English - Duration: 1 hour, 10 minutes

    This webinar is in two parts. The first part gives a brief introduction to the Ph. Eur., some background into the history of this general chapter and highlight the changes that were introduced in Ph. Eur. (Supplement 8.3). The second part focusses on the revision of the chapter with an overview on hydrolytic resistance and delamination risk.

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    Reverse osmosis in the Ph. Eur. monograph for Water for Injections (WFI)

    Reverse osmosis in the Ph. Eur. monograph for Water for Injections (WFI) (Webinar recorded on 22 April 2015)
    Language: English - Duration: 1 hour, 10 minutes

    This webinar starts with a general introduction to the Ph. Eur. and the background of this history of water monographs. It also gives an overview of actions taken by the Ph. Eur. towards the revision of the WFI monograph, an update on the status of the revision of the WFI monograph and the consequences of the revision on other Ph. Eur. texts covering quality of water.

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    Call for experts

    Call for experts (Webinar recorded on 7 July 2016)

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