Webcode 25092603
Kora Doorduyn-van der Stoep
Medicines Evaluation Board MEB), Utrecht, THE NETHERLANDS
Chairperson CMDh EU representative at the MEB; Kora Doorduyn works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures - Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).
Pablo López Bajo
ASPHALION S.L., Barcelona
Pablo López is a Regulatory Affairs Manager at Asphalion with 8 years of experience in Regulatory Affairs. Pablo has a strong background in Regulatory Affairs Life Cycle Management in several kind of procedures in Europe. He is committed to personal and professional development and ensuring the achievement of company's objectives and is always seeking opportunities to reach professional milestones Previously, he worked as a Regulatory Affairs Technician at such big companies like Teva Pharma or Insud Pharma where he gained valuable experience in other Regulatory fields like CMC, Labelling or Publishing apart from Local registers in Spain (AEMPS). Pablo holds a Master in Pharmaceutical Industry from Universidad Complutense of Madrid completing his degree in Veterinary Medicine. He is passionate about his job and is fully dedicated to improve his leadership abilities as a Manager.
Dr. Regina Heckenberger
Bayer AG, Wuppertal, Germany
Head of Regulatory CMC Wuppertal; Regina is a biologist by training holding a PhD in Natural Sciences and has over 20 years' experience in regulatory affairs. She and her team is specialized on regulatory CMC topics and works on life-cycle management for small and large molecules, on NDAs/MAAs as well as on development projects and respective quality support for CTA/INDs.
Dr. Elke Löber
Senior CMC Regulatory Affairs Manager at Boehringer Ingelheim International GmbH.
Dr. Elke Löber is Senior CMC Regulatory Affairs Manager at Boehringer Ingelheim International GmbH, where in the last 14 years she was responsible for worldwide submissions and post approval life cycle management of new chemical entities. Between 2001 and 2011 she held positions within Boehringer Ingelheim Pharma GmbH and Co. KG within Quality Management as head of laboratory for in-process control testing as well as drug substance project manager for new chemical entity drug substance development. She holds a PhD in Chemistry from the University of Kaiserslautern and worked as postdoctoral associate at the Yale University, USA.
08-09/09/2025
08-09/09/2025
Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: EU Variation System and Procedures
, online
Your booking advantage: You register for the seminar at the regular price and add the e-Learning. The price of the e-Learning is reduced by €100 (€390 instead of €490 plus VAT).
390,00 €
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFER
e-Learning: EU Variation System and Procedures
, online
Your booking advantage: You register for the seminar at the regular price and add the e-Learning. The price of the e-Learning is reduced by €100 (€390 instead of €490 plus VAT).
390,00 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course.
This training will bring you the latest information in the planning, classification and submission of variations. All relevant changes related to the new Variation Regulation (applicable since 01.01.25) will be discussed.
Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation (e-)application form and organisation of grouping and worksharing.
Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the classification guideline and the Q&A paper will reinforce your knowledge.
In this seminar you will gain hands-on knowledge on
09:00 Welcome and introduction
09:15
Pablo López Bajo
10:00
Pablo López Bajo
10:30 Coffee break
10:45
Kora Doorduyn-van der Stoep
11:15
Pablo López Bajo
12:00 Lunch break
13:00
Kora Doorduyn-van der Stoep
14:00 Short break
14:15
Pablo López Bajo
15:30 Coffee break
15:45
Pablo López Bajo
16:15 Q&As and outstanding questions
16:45 End of seminar day I
09:00
Elke Löber
10:30 Coffee break
10:45
Dr. Regina Heckenberger
12:15 Lunch break
13:15
Elke Löber
14:30 Coffee break
14:45
Dr. Regina Heckenberger
16:00
All speakers
16:45 Q&As and outstanding questions
17:00 End of online seminar
Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.
This e-Learning provides you with in-depth knowledge about the classification, grouping, and submission of variations in the EU. It covers both procedural and content-related aspects.
Upon completion of the e-Learning, you will be familiar with the key principles of variation submissions and will have a solid foundation for your work in this area.
Please register for the seminar "Variations in Europe" by clicking "Register" or "Book". You will receive a €100 discount if you also book the e-Learning (the invoice will then be €390 + VAT instead of €490 + VAT).
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
of 5 stars of all ratings from 2024
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Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
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From this seminar I expected to learn more about regulatory activities, in particular on quality changes, and know more about the experiences of other colleagues. I think that it met all my expectations.
Good organisation and interesting topics in a nice atmosphere.
I appreciated all the topics. The seminar was were structured, starting from an overview of all types of variations and line extensions, then focusing on quality changes with some case studies. I found all the advices on how to manage the documentation correctly.
Useful to deepen several aspects of regulatory activities.
2 Days with a full package on information required for regulatory managers working in/for Europe.
