EDQM Overview of our products and services

Transcription

1 EDQM Overview of our products and services Guide to the Quality and Safety of Organs for Transplantation EDQM 6th Edition

2 CombiStats : statistical analysis software computer program for calculations in accordance with chapter 5.3 of the European Pharmacopoeia. EUROPEAN PHARMACOPOEIA European Pharmacopoeia 2017 UPDATE ( ) The earliest access to the European quality standards Applicable in 38 European countries and used in over 100 worldwide. Continuously updated, with new and revised texts published three times a year. Delivers crucial information earlier than any other Pharmacopoeia. NEW format just released for 9.3: downloadable version with direct access to the Knowledge database. Available in both online and print formats; QR codes for direct access to the Knowledge database. A number of packages are available. Unlimited licences and discounts applicable for multiple licences. Do not hesitate to contact the EDQM for a quotation. Includes free access to the online archive. Commission Sessions Session No. Date Edition/ Supplement Publication schedule For more information visit the EDQM Store Corrections to be taken into account as soon as possible and not later than Implementation date 153 November th Edition July August January March October November April June January February July November July August January March October November April June January February July November July August January March October November April June January February July November th Edition July August January 2020 Pharmeuropa Online: the Ph. Eur. free forum Help us to shape the future Pharmacopoeia Ph. Eur. texts for comment: published continuously, with 4 deadlines for comments per year. Pharmeuropa Bio & Scientific Notes: news in the biological standardisation area and scientific articles linked to the work of the Ph. Eur. Pharmeuropa archives: free access to 30 years of electronic archives. Other products of interest: Online Knowledge Database for information on a substance or text in the Ph. Eur.: Technical Guides and the Ph. Eur. Style Guide are available here: Standard terms database Free resource to be used in Marketing Authorisation dossiers Contains standard terms for pharmaceutical dose forms, routes and methods of administration, containers, closures, delivery devices, combined terms and patient-friendly terms for medicines for human and veterinary use. European Union Guideline status: must be used in marketing authorisation applications for medicines (i.e. the Application Form and the Summary of Product Characteristics (SmPC)). 952 individual terms and over translations in 33 languages.

3 Practical information: The EDQM distributes WHO ISA and WHO ICRS. Online Catalogues updated daily: RS searchable by code, name or CAS number to quickly locate the standard you need. Safety data sheets (SDS), leaflets and study reports (only for ISA) available online (PDF format): REFERENCE STANDARDS European Pharmacopoeia Reference Standards (RS) Discover the 84 new RSs established in 2016 Over 2700 RS items available: chemical, herbal and biological reference standards and materials and reference spectra. Necessary for the application of Ph. Eur. monographs. Carefully established and monitored by the EDQM laboratory. Online RS Catalogue updated daily: RS searchable by code, name, monograph number or CAS number to quickly locate the standard you need. Contains RS Batch Validity Statement (BVS) enabling users to verify, at time of use, the validity of batches supplied. Contains downloadable Safety data sheets (SDS) and leaflets (where applicable). Who International Standards for Antibiotics (ISA) and Who International Chemical Reference Substances (ICRS) ISA: reference substances for use as primary standards in microbiological testing of antibiotics. ISA can also be used by regional or national pharmacopoeias to establish secondary standards. ICRS: primary chemical reference substances. They are supplied for use in physical and chemical tests and assays described in the International Pharmacopoeia or other WHO quality assurance documents. CERTIFICATION OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA (CEP) Certificates of Suitability to the Ph. Eur. monographs (CEP) Make a difference to your business For active substances or excipients covered by a monograph in the Ph. Eur., including herbal products; any product with TSE risk. Centralised evaluation of quality dossiers. Replace the detailed data in quality parts of marketing authorisation applications (MAA) and facilitate the management of MAA. Recognised throughout all 38 Ph. Eur. member states and beyond. Complemented by a risk-based inspection programme of manufacturing sites. Practical information: For more information on the Certification procedure:

4 Committee of Experts on Packaging Materials for Food and Pharmaceutical Products P-SC-EMB THE HEALTHCARE COLLECTION The EDQM regularly produces publications related to HealthCare activities including: Blood Transfusion & Organ, Tissues and Cells Transplantation Cosmetics & Food Contact Materials Pharmaceutical Care OTHER PRODUCTS AND SERVICES OF INTEREST Combatting Counterfeit Medicines Guide to the quality and safety of ORGANS FOR TRANSPLANTATION Guide to the quality and safety of TISSUES AND CELLS for human application European Committee EDQM (Partial Agreement) 6 on Organ Transplantation th Edition (CD-P-TO ) 2016 European Committee (Partial Agreement) on Organ Transplantation (CD-P-TO ) EDQM 2 nd Edition 2015 Metals and alloys used in food contact materials and articles A practical guide for manufacturers and regulators European Directorate for the Quality of Medicines & HealthCare st Edition Pharmaceutical Care Policies and Practices for a Safer, More Responsible and Cost-effective Health System Consumer Health Protection Committee (CD-P-SC) 2016 GUIDANCE ON ESSENTIAL OILS in cosmetic products Proficiency testing studies (PTS) are carried out on basic methods of analysis in the biological and physico-chemical fields within the framework of ISO/IEC Blood Proficiency testing studies (B-PTS) are also organised to determine the performance of blood transfusion screening laboratories responsible for testing individual blood donations EDQM Publications are available in a variety of formats, printed, downloadable or e-publications. FREE EDQM publications can be downloaded quickly and easily from this new publications management tool: See our latest online catalogue above or visit the EDQM Store Events, training sessions, webinars and conferences are organised all year round. A unique opportunity to interact directly with the EDQM, experts and key speakers from around the world.

5 IMPORTANT INFORMATION FOR USERS All EDQM publications are hologram-labelled and bear a unique Publication ID (EPID code). Use your EPID code to register your publication, check its authenticity or have access to our support team (HelpDesk) go to: The EPID code is sent by when you purchase the USB stick or any of the online versions of the European Pharmacopoeia. HOW TO KEEP UP TO DATE? Visit our website: 1 Colourful areas 2 Mirrored mini-text 3 Colourful letters and stars 4 Lens effect ORDERING EDQM PUBLICATIONS Prices and availability to be found under each product item on: ORDERING REFERENCE STANDARDS Catalogues: Order forms: CRS: ISA: ICRS: SALES ORDER CONTACTS orders@edqm.eu with the order forms as an attachment Helpdesk Publications: Helpdesk Reference substances: Tel.: +33(0) Press 2* Payments can be made by bank transfer or credit card via the EDQM Store: Register today for our free E-Newsletter at: Follow us on Twitter: Free user support service: Frequently Asked Questions (FAQ) and HelpDesk. Please check the FAQ section to see if your question has already been answered: Postal address: European Directorate for the Quality of Medicines & HealthCare (EDQM) 7 allée Kastner, CS 30026, F Strasbourg France * Omit the 0 if calling from outside France.

6 This publication presents an overview of the Products and Services available in 2016 from the European Directorate for the Quality of Medicines & HealthCare, Council of Europe. PREMS PPRDD ENG The Council of Europe is the continent s leading human rights organisation. It comprises 47 member states, 28 of which are members of the European Union. The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its mission is to contribute to the basic human right of access to good quality medicines and healthcare and to promote and protect public health. European Directorate Direction européenne for the Quality de la qualité of Medicines du médicament & HealthCare & soins de santé