Pharmacopeial compliance and marketing authorisations in Europe Masterclass - EU edition
15-16 October, 2024
Pharmacopoeias play a major role in quality standards for the manufacture and control of medicines in Europe and worldwide
In this training course, you will learn how to deal with the requirements of individual and general monographs and how to apply general chapters. In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on the implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question-and-answer sessions.
15-16 October, 2024, Virtual
Time Zone:UTC/GMT+1 /CET
Overview
To protect public health and ensure the availability of high-quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU. The European system offers different routes for such an authorisation, but there is only one set of common rule. Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine. This seminar provides the relevant know-how on the authorisation of medicinal products in Europe. You will learn which authorisation routes are possible and which documents you need for authorisation. The special features of the authorisation of active substances are also covered. You will also learn about the special features of the authorisation of active substances and the prominent role of the European Pharmacopoeia in ensuring the quality of medicinal products.
Pharmacopoeias play a major role in laying down quality standards for the manufacture and control of medicines in Europe and worldwide. These quality standards mostly cover active pharmaceutical ingredients and excipients both, in their original state and in the form of pharmaceutical preparations.
In this training course you will learn how to deal with requirements of individual and general monographs and how to apply general chapters. In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question and answer sessions.
Detailed information will be provided on impurity control, including nitrosamines and elemental impurities.
#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #Pharmacopoeialcompliance #europemarketingauthorisation
EDQM, Council of Europe
Until 2008 Pharmaceutical Assessor (BfArM) for the Quality Assessment of MAAs and Variations (National Procedure, MRP, DCP, Centralised Procedure), Peer Review in Centralised Procedures, Inspections according 25 (5) German Drug Law (AMG), Quality Assessment for the National Advice procedure and the Scientific Advice Procedure of the EMA
2009-2011 Senior Scientific Officer (EDQM) for the Quality assessment of New Dossiers, Technical Advice
2012-2013 Pharmaceutical Assessor (BfArM)
2013-2021 Desk Officer Federal Ministry of Health (BMG), Medical Devices
Former member of the Quality Working Party at EMA
Former member of the Inhalanda Working Party at EDQM
Former member of the Propellant Working Party at EDQM
She continues to work as a trainer in marketing authorisation procedures with a focus on pharmaceutical quality.
RECOMMENDATION
Who should attend?
Quality control managers
Quality assurance managers
Inspectors
Regulatory affairs
CMC managers
Marketing authorisation
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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