3-day workshop for beginners in EU drug regulatory affairs
Webcode 24062610
Gabriele Eibenstein M.A.
Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs with a high level of expertise in European approval procedures (esp. MRP & DCP) and simplified procedures
Dr. Christian M. Moers
Sträter Lawyers, Bonn, Germany
Lawyer;
His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows:
- European and German medicinal product law
- Marketing authorisation law & regulatory affairs
- Pharmacovigilance
- Wholesale trade with medicinal products, distribution of medicinal products
- Manufacture of medicinal products
More information please click here.
Émanuela Negri
Regulatory Affairs, Compliance and Pharmacovigilance Consultant, ITALY
Regulatory Affairs, Compliance and Pharmacovigilance Consultant, ITALY
Dr.ssa Ida Caramazza
Senior Expert Regulatory Affairs, ITALY
Ida Caramazza has a Degree in Pharmaceutical Technology and Chemistry and a Diploma as Specialist in Toxicology . She has been working in the Pharmaceutical field since the '80s. Her experience started with preclinical research activity in Pharmaceutical Companies and then continued in the regulatory affairs sector, working for Regulatory Consultancy Firms and for international Pharmaceutical Companies, being involved in Regulatory Affairs activities mainly on medicinal products, but also on other healthcare products, such as medical devices, food supplements and cosmetics. Currently she works as Senior Regulatory Affairs Consultant on regulatory strategy projects, regulatory activities, training in regulatory field. She is also involved in teaching activities at University masters in Regulatory Sciences.
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, Oss, THE NETHERLANDS
Regulatory Consultant
More information please click here.
Karl-Heinz Loebel
PharmaLex GmbH, Mannheim; GERMANY
Director, Principal Consultant Regulatory Operations
Nach seinem Studium war Herr Loebel mehrere Jahre Mitarbeiter der Universität Heidelberg bevor er im Jahr 2000 zu einem Biotechnologie-Startup-Unternehmen wechselte. 2005 begann seine Laufbahn bei der PharmaLex GmbH, Mannheim, wo er zunächst die Position des Head of Regulatory Operations und seit 2014 die Position des Associate Director Regulatory Operations innehat. Sein Aufgabengebiet umfasst u.a. die Betreuung elektronischer Einreichungen, Projektplanung und die strategische Beratung von Pharma-Unternehmen in diesem Bereich.
More information please click here.
05-07/06/2024
05-07/06/2024
Day 1: 09:00 - 17:00
Day 2: 09:00 - 17:00
Day 3: 09:00 - 17:00
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
The fee includes a comprehensive e-documentation for download and a certificate
OPTIONS
Day 1
+0,00 €
Day 1 + 2
+800,00 €
Day 1 + 2 + 3
+1.600,00 €
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
The fee includes a comprehensive e-documentation for download and a certificate
OPTIONS
Day 1
+0,00 €
Day 1 + 2
+800,00 €
Day 1 + 2 + 3
+1.600,00 €
Dr. Rebekka Bitsch
Conference Manager
+49 6221 500-565
r.bitsch@forum-institut.de
Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on all important issues. The training course will be entirely held in English.
This online introductory training course will inform you about all the important obligations and challenges in regulatory affairs.
You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory lifecycle management for a product and the structure and submission of an electronic dossier.
Book day 1, day 1 and 2 or all three days, according to your needs! A preparatory e-Learning is included in your booking.
In this seminar you will
09:00 - 17:00 Workshop 1: Basic principles of drug regulatory affairs
09:00 - 09:15 Welcoming and introduction round
09:15
Dr. Christian M. Moers
10:30 Coffee break
10:45
Dr. Christian M. Moers
12:00 Lunch break
13:00
Gabriele Eibenstein M.A.
14:15
Gabriele Eibenstein M.A.
15:45 Coffee break
16:00
Dr. Christian M. Moers
16:45 Q&As Day 1
17:00 End of Day 1
09:00 - 17:00 Workshop 2: Marketing Authorisation Documents
09:00 Welcoming and introduction round
09:15
Émanuela Negri
10:15
Émanuela Negri
11:15 Coffee break
11:30
Émanuela Negri
12:30 Lunch break
13:15
Émanuela Negri
14:45
Dr.ssa Ida Caramazza
15:40 Coffee break
15:50
Dr.ssa Ida Caramazza
16:50 Q&As Day 2
17:00 End of Day 2
09:00 - 17:00 Workshop 3: Regulatory Life Cycle Management
09:00
Ingrid Prieschl
10:45 Coffee break
11:00
Ingrid Prieschl
12:30 Lunch break
13:30
Karl-Heinz Loebel
15:00 Coffee break
15:15
Karl-Heinz Loebel
16:50 Q&As Day 3
17:00 End of Seminar
June 05, 2024
June 06, 2024
June 07, 2024
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
Dieses Seminar gibt Ihnen Tipps zur besseren Verfahrensbegleitung im MRP und DCP und zum Lifecycle-Management in Europa
Erhalten Sie in diesem Seminar einen umfassenden Überblick über den komplexen regulatorischen Rahmen für klinische Prüfu...
Dieses Online-Seminar vermittelt Ihnen essenzielles Know-how zu eCTD-Spezifikationen, eSubmission-Notwendigkeiten, natio...
Virtuelles Aufbauseminar zu weitergehenden Verantwortlichkeiten und Pflichten des/der Großhandelsbeauftragten
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
We provide flexible education and training with high-quality e-Learning programmes for several topics.
Details
Here you can find the technical requirements for our online events that must be met.
Details
We are now officially certified to ISO 9001 and ISO 21001 standard.
Details
