Annual CMC Conference
Regulatory Update, practical aspects and current challenges in 2019
- QbD elements in manufacturing
- Impurities in active substances - Lessons learned from Valsartan
- Revisions of CEPs
- ICH Q12 - less burden due to quality related changes?
- Comparative assessment of quality attributes - Statistical opportunities
- Workshop: Quality related changes
- Quality requirements of medicinal products containing a device component
This distinguishes our event
Aims and objectivesDo you work in regulatory affairs/CMC or quality assurance?
Then you shouldn’t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends.
Join the in-depth discussion on new developments, including:
- QbD elements
- ICH Q12
- Statistical opportunities
- and much more.
Conference Manager Pharma & Healthcare
- Marketing authorisation/regulatory affairs/CMC
- Quality assurance/quality control/analytics
2nd Day: 9.00-17.00
- The new guideline on Manufacture of the finished dosageg
- Are QbD elements on the rise?
- Implementation in the manufacturing part of Module 3
10:45 Coffee break
- Update on regulatory requirements on impurities
- Valsartan: Impact on authorities and industry
- Analytical challenges: Mission (im)possible?
- Worst case: Recall. What CMC/Regulatory Affairs should know
- What can we learn from Valsartan?
- Maintenance of a CEP and new EDQM requirements
- Revision background: Fast acceptance; avoiding delay
- Types of revisions and examples, including sister files
- When are CEPs revised?
15:15 Coffee break
- Essentials of data integrity
- Change management and data integrity requirements
17:00 End of day 1
- Current status of ICH Q12
- What is the expected impact?
- Any change compared to the current situation?
10:00 Coffee break
- Current draft reflection paper
- Scope and principles
- Impact on the classification of changes and the change management process
- Manufacturing process
- Analytical method
14:45 Coffee break
- Current regulatory requirements
- CMC challenges
17:00 End of conference
She is scientist at the Federal Institute for Drugs and Medical Devices in the assessment of the quality of the dossier since 1991 and experienced in the assessment of pharmaceutical dossiers for marketing authorisation applications of medicinal products. She has broad knowledge of the national and EU regulations of medicinal products as well as of the corresponding EU guidelines and the European Pharmacopoeia. Since 2000 she is assessor for the Certification Procedure (EDQM) in Strasbourg. She was member of the Technical Advisory Board (TAB) from 2001 to 2010, chairperson of the TAB from 2005 to 2010 as well as member of the Quality Working Party from October 2007 to February 2011. She is member of the Inhalanda Working Party, EDQM, Strabourg since 2013.
Senior Expert Trace Analysis & Structure Elucidation
Global Head Statistics and PAT
Scientific Officer & Head of Section for Revisions within the Certification of Substances Department Dr Andrew McMath graduated in Pharmacy from the School of Pharmacy Portsmouth, UK and was registered with the Royal Pharmaceutical Society of Great Britain from 1987 to 2004. Following registration he worked in retail and hospital pharmacy and then in teaching. He studied for a post-graduate degree followed by a PhD in Medicinal Chemistry at ‘la Faculté de Pharmacie’, Université Paris V. He received his PhD in 1997. He then joined l’Agence du Médicament, Paris (now ‘Agence nationale de sécurité du médicament et des produits de santé’) as Pharmaceutical Assessor. In 1999, he joined the EDQM Certification of Substances Division as Scientific Officer. After having assumed the role of Head of Section for new applications he is currently Head of Section for Revisions within the Certification of Substances Department.
Nähere Informationen finden Sie hier.
Director, Regulatory Compliance Management
Keine ausführliche englische Beschreibung vorhanden
Head Clinical Affairs, Expert Medical Devices
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Phone: +49 69 770670-0
Fax: +49 69 770670-444
- CMC experts from the industry and from international authorities share their expertise with you.
- Advanced practical information will be obtained.
- Issues beyond your own specific area will be addressed.
Very skilled, high level speakers
Member of authorities as speaker. I totally enjoyed the presentations.
Interaction with the speakers e.g. during lunch, coffee breaks good starting times!
After having attended this course, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.
05.07.2019 in Frankfurt
This seminar provides you within-depth knowledge on marketing authorisation, CMC documents and GMP-requirements in Russia, Belarus, Kazakhstan and Ukraine.
03. - 05.06.2019 in Frankfurt