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).
Lidia Cánovas
ASPHALION S.L., Barcelona, SPAIN
General Manager, Regulatory Affairs Director; Lidia Cánovas has over 25 years of global drug development and regulatory affairs experience in the biopharmaceutical industry. She received her degree in Pharmacy from the University of Barcelona, and has a Master in Business Administration in the Pharmaceutical Industry. She is currently the General Manager - Regulatory Affairs of Asphalion, S.L., a consulting company specialized in drug development and regulatory affairs; which she joined in 2003. With over 80 employees with backgrounds in all areas of life science, Asphalion's consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.Her main activities focuses on consulting and strategic management of projects in the area of Regulatory Affairs and Development for Europe and USA, actively participating in Scientific Advice, Pediatric Plans, Orphan Drug Designations, Development Plans, Centralized Procedures, Decentralized and Mutual Recognition in permanent contact with the regulatory authorities. She has extensive regulatory and development experience in innovative, biological, biotech, biosimilars and advanced therapy products.
Dr. Veronika Alt
Cencora PharmaLex, Germany
Director Regulatory Affairs Veronika has over 17 years' experience in regulatory affairs. She works on the life-cycle management of several MAAs and successfully completed many post-marketing CMC variations for biological medicinal products. Veronika is also involved in other relevant areas such as management of post-approval PIP management, CMC change control review, MA renewals, MA transfers etc. She has a scientific background with a doctoral degree in technical chemistry (biotechnology).
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.
André Mota
ASPHALION S.L., Madrid Office, SPAIN
Regulatory Affairs Director,
Madrid Office
André has more than 14 years' experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different countries, with several types of products, and for different types of companies.
Besides his core CMC expertise, he is mainly focused on CMC writing and strategic guidance, he has also been deeply involved in other relevant areas, such as:
- Project lead/management of global projects,
- Implementation of EMA Policy 0070 (clinical data transparency), and
- eCTD publishing.
More information please click here.
15-16/05/2024
15-16/05/2024
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 - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
The seminar days may also be booked seperately:
Both days: € 1,890.00 (+ VAT)
Single day: € 1,190.00 (+ VAT)
OPTIONS
Combination Day 1 + Day 2
+700,00 €
Day 1
+0,00 €
Day 2
+0,00 €
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
The seminar days may also be booked seperately:
Both days: € 1,890.00 (+ VAT)
Single day: € 1,190.00 (+ VAT)
OPTIONS
Combination Day 1 + Day 2
+700,00 €
Day 1
+0,00 €
Day 2
+0,00 €
SPECIAL OFFER
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room! The training course will be entirely held in English.
This training will bring you the latest information in the planning, classification and submission of variations.
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.
An extract from last year's participant feedback:
Welcome and introduction
Lidia Cánovas
Lidia Cánovas
Coffee break
Kora Doorduyn-van der Stoep
Lidia Cánovas
Lunch break
Kora Doorduyn-van der Stoep
Lidia Cánovas
Coffee break
Lidia Cánovas
André Mota
End of seminar day I
André Mota
Coffee break
Dr. Regina Heckenberger
Lunch break
Dr. Veronika Alt
Coffee break
Dr. Regina Heckenberger
All speakers
Q&As and outstanding questions
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.
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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 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
Wie werden die aktuellen GDP-Anforderungen in die Praxis umgesetzt? In unserem Seminar & Workshop erhalten Sie pragmatis...
Der/die Regulatory Affairs Manager*in ist Neuzulassungsmanager*in, Fristenmanager*in, Dokumentenmanager*in und Projektma...
Welche Änderung in Analytik und Herstellung bedingt welchen Typ Änderungsanzeige? Online-Seminar zur Klassifizierung und...
Flexibler Online-Lehrgang zum Verständnis des rechtlichen/regulatorischen Umfelds der Pharmaindustrie
Try out our e-Learning programmes free of charge and without any obligation.
DetailsThis whitepaper describes the principles of post-approval change management protocols (PACMP) and the related guideline ...
DetailsWe are now officially certified to ISO 9001 and ISO 21001 standard.
Details
Good general overview.
Good organisation and interesting topics in a nice atmosphere.
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.
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.