- Online training -
Webcode 22082451
Christine Hirt
MAIN5 GmbH & Co. KGaA, Frankfurt, GERMANY
is Management Consultant and responsible for regulatory business consulting at MAIN5. She has more than 20 years of experience in the field of Regulatory Affairs working for industry and authority representatives. Christine is internationally recognized on expert level for regulatory business processes, guidelines and regulations. She is an active member in several associations, such as DIN/ISO TC/WG6, IRISS, BPI and MEGRA. Participating actively in the IDMP adoption expert group of WG6/TC215/ISO and other expert groups associated with implementing RIMS and IDMP.
Renato Rjavec
Amplexor Life Sciences, SLOVENIA
Director of Product Management, Life Sciences
Sven Harmsen
e-DRA Harmsen - a service provider for electronic drug regulatory affairs, Munich, Germany
Senior Consultant;
Sven is a freelance consultant with focus on Document Management, eSubmissions, Regulatory Affairs Information Management and other GxP applications. He has worked over 20 years in the biopharmaceutical industry as leader of global IT projects and teams. Sven brings structure to complex situations like business processes, projects or system architectures and he has a deep knowledge of computer system validation.
More information please click here.
Dr Anna Thaidigsmann
EXTEDO, London, UNITED KINGDOM
Senior Regulatory Consultant
30. - 31.08.2022
30. - 31.08.2022
Both days: 09:00 am - 5:00 pm - semi...
Both days: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts.
online
online
Veranstaltung - 1.790,- € zzgl. MwSt.
The participation fee includes a comprehensive documentation for download and a certificate.
Online-Seminar: € 1.790,00 (+ 21 % MwSt.)
Additional e-Learning (optionaly bookable): € 290,00 (+ 21 % MwSt.)
Veranstaltung - 1.790,- € zzgl. MwSt.
The participation fee includes a comprehensive documentation for download and a certificate.
Online-Seminar: € 1.790,00 (+ 21 % MwSt.)
Additional e-Learning (optionaly bookable): € 290,00 (+ 21 % MwSt.)
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.
This online seminar will familiarise you with electronic submission requirements in regulatory affairs and enable you to further professionalise your submission management. It will also identify the data you need for IDMP and SPOR and show you how to optimise your data integrity management.
This online seminar is aimed at all specialists and managers entrusted with the electronic submission of marketing-authorisation-related documents or responsible for the regulatory databases.
Basic eCTD knowledge is advantageous.
09:00 Welcome and introductory round
09:15
Dr Anna Thaidigsmann
12:30 Lunch break
13:30
Renato Rjavec
14:30
Renato Rjavec
15:15 Coffee break
15:30
Christine Hirt
16:45 Summary and outstanding questions
17:00 End of training day I
09:00
Sven Harmsen
10:30 Coffee break
10:45
Dr Anna Thaidigsmann
12:15 Lunch break
13:15
Sven Harmsen
14:45 Coffee break
15:00
Sven Harmsen
16:45 Summary and concluding discussion
17:00 End of training course
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to b.wessels@forum-institut.de
Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.
Do you need practical expertise in editing essential marketing authorisation documents and compiling an eCTD? Do you need to make a baseline submission and thus seek practical advice?Then, we would recommend the 'eCTD preparation and submission' e-learning programme.
This e-Learning consisting of three recorded webcasts will show you step by step how to develop the relevant documents, compile them and submit an eCTD.
The online training programme "eCTD preparation and submission" comprises three didactic modules in which the expert share his expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the three modules and passed the multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Overall impression: 100% of the participants’ feedback was very good or good. (June 2019)
Course content: 100% of the participants’ feedback was very good or good. (June 2019)
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Details
This is what participants in June 2019 liked most about the event.
The speaker have lot of experience and are updated on the latest news especially about eCTD.
The possibility to exchange experience and to ask / receive suggestions and how to manage particular siutuations / cases.
Very good organisation. High quality of speakers.
This event covered all relevant topics around eSubmisson.
Comment of former participants (June 2019).
Well organised. No kind os issues at all. Staff full availabilty. Speakers updated on the last changes on this matter.
Dr.ssa Silvia Immediato.
Alfasigma S.p.a
Good update on regulatory information (eSubmission, XEVMP, IDMP). Good speakers.
