Webcode 26092603
Carmen Bas Jiménez
Asphalion, S.L., Barcelona, SPAIN
Senior Regulatory Affairs Officer I am pharmacist working as a Senior Regulatory Affairs Officer at Asphalion, within the Life Cycle Management team. I have almost five years of experience in the Pharmaceutical Industry. My experience is based on the compilation, update, and review of dossiers at EU and International levels, specializing in other regions such as Latin America, Asia Pacific, and Middle East, as well as submission management in US and CA. Also, I previously worked as a Regulatory Affairs Associate at the company Chemo, which is one of the different business areas that belongs to the Insud Pharma Group.
Ingrid Prieschl
Zwiers Regulatory Consultancy B.V., A ProductLifeGroup Company, Oss, THE NETHERLANDS
Regulatory Consultant
More information please click here.
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.
28 - 29/09/2026
28 - 29/09/2026
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
Simply register for the seminar and receive a €100 discount on the e-learning (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
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
Simply register for the seminar and receive a €100 discount on the e-learning (€390 + local VAT rather than €490 € + local VAT) if you book it simultaneously.
390,00 €
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de
Variation regulation, classification guideline, eSubmission and 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) and Guideline (applicable as of 15.01.26) 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
Carmen Bas Jiménez
10:00
Carmen Bas Jiménez
10:30 Coffee break
10:45
Ingrid Prieschl
11:15
Carmen Bas Jiménez
12:00 Lunch break
13:00
Ingrid Prieschl
14:00 Short break
14:15
Carmen Bas Jiménez
15:30 Coffee break
15:45
Carmen Bas Jiménez
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
This e-Learning will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.
Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.
Simply register for the seminar by clicking 'Register'. You will receive a €100 discount if you also book the e-learning (€390 + local VAT rather than €490 + local VAT).
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.
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
of 5 stars on Trustpilot = good
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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.
