Time: 10:30 am -11:30 am (CET, Paris)
Duration: 45 minutes + 15 minutes for questions
The objective of this live, interactive webinar is to present the most frequent questions raised after the initial evaluation of new applications for European Pharmacopoeia Certificates of Suitability (CEP) for chemical purity. It is designed to assist applicants understand and become familiar with CEP application requirements and improve the quality of their dossiers so as to facilitate and avoid delays in the granting of their CEPs.
The presentation will cover the following topics:
- Brief overview of the current EDQM guidelines and policies related to new dossier applications
- A summary of each of the deficiencies and common problems encountered during evaluations
- Requirements, recommendations and practical advices on how to avoid the different deficiencies
- A focus on real world examples and the pitfalls to watch out for
The webinar will be provided by Mrs Alma Kiso, Scientific Officer and Mr Cristian Sampaolesi, Head of Section for New Dossier Applications, Certification of Substances Department, EDQM, Council of Europe.
About the Presenters
Alma Kiso, BSc, MSc, is a Scientific Officer in charge of assessment of new CEP applications. Before joining the EDQM, Alma was in charge of assessment of new applications for marketing authorisation for medicinal products for human use with the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. She was also member of the European Pharmacopoeia Commission and secretary of the National Pharmacopoeia Authority of Bosnia and Herzegovina. She has been working with the Certification of Substances Department of the EDQM since October 2016.
Cristian Sampaolesi, BSc, MSc, is the Head of the Section in charge of assessment of new CEP applications. After having worked in the pharmaceutical industry for 5 years, Cristian joined a European National Competent Authority as Quality Assessor in 2009, a position he held for 3 years. From 2010 to 2012, he was a member of the Joint CHMP/CVMP Quality Working Party at the EMA. He has been working with the Certification of Substances Department of the EDQM since June 2012.
Who should attend
Manufacturers of chemically-defined substances for pharmaceutical use who are interested in applying for CEP’s, who deal already with CEP applications or that would like to better understand the basis of the evaluations performed by the EDQM should attend this webinar. The webinar is ideal for professionals working in quality control/compliance, manufacturing and regulatory affairs.
Participation is FREE OF CHARGE.
Prior to the webinar you have the possibility to submit general questions which you would like to have addressed in the webinar via a question form. Due to organisational reasons, these questions should be submitted not later than 3rd April.
No special software is necessary for the webinar. If you wish to connect to audio using VoIP (Voice over Internet Protocol) you will need a fast Internet connection, a microphone and speakers. A USB headset is recommended. The VoIP connection is free.
You are strongly advised to consult your IT Department to ensure your computer can receive the webinar and that the following domain name are neither rejected nor blocked as spam, otherwise you will not receive the link to connect to the webinar: @gotowebinar.com and @care.gotowebinar.com.