- Online training -
Webcode 24062472
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut, (PEI), Langen
Jörg Engelbergs holds a doctorate in biology with a focus on cell biology and biotechnology and has held various positions in the field of experimental cancer research as a research group leader, including at the West German Tumour Centre WTZE. He currently works for the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedicines, as a scientific-regulatory expert and reviewer in the areas of pharmaceutical quality, non-clinical and personalised medicine in the context of the entire life cycle of biopharmaceuticals. Furthermore, as a product-specific expert, he accompanies national GMP inspections and those carried out in third countries (USA/Asia) and is a member of various European regulatory working groups such as the "European Directorate for the Quality of Medicines & HealthCare" (EDQM; Host-Cell Protein Working Party, P4Bio/Biosimilar Working Party) and the "European Medicines Agency" (EMA; Methodology Working Party, CDx Consultation Working Party).
Dr. Josef Gabelsberger
Roche Diagnostics GmbH, Penzberg
Josef Gabelsberger studied biology and biotechnology at the Technical University of Munich, where he gained his doctorate in microbiology. He then worked for a total of 15 years, first at the Munich Gene Centre and then at a medium-sized biotech company in Munich in the field of process development for the production of therapeutic vaccines and oncolytic viruses. Since 2006, he has been employed at Roche Diagnostics GmbH in Penzberg, where he led the technical fermentation development of monoclonal antibodies for over a decade. Since 2020, Josef Gabelsberger has been Technical Development Manager of a gene therapy project.
Dr. Monika Geiger
Senior Principal Scientist, Drug Product Services Lonza AG, Basel
Dr Monika Geiger completed her studies in pharmacy at the Philipps University in Marburg in 1997. She received her licence to practise in 1997. Until 2015 she was Senior/Principal Scientist at Pfizer. She is currently Senior Principal Scientist and Principal Group Leader, Formulation Development, Drug Product Services at Lonza AG in Switzerland.
Dr. Sonja Matt
Paul-Ehrlich-Institut (PEI), Langen
Sonja Matt has been working as a scientific assessor at the Paul-Ehrlich-Institut since 2016 and evaluates the pharmaceutical quality of monoclonal and polyclonal antibodies. Between 2018 and 2020, she participated in and successfully completed the Master's programme "Drug Regulatory Affairs" at the University of Bonn.
Dr. Anika Schröter
Dr. Anika Schroeter e.U., Vienna, Austria
Anika Schröter holds a PhD in toxicology and is a registered European Registered Toxicologist. Since 2014 she has been working as a consultant for clients in the pharmaceutical and biotech industry on issues related to non-clinical drug development (e.g. small molecules, biologics, vaccines). Her expertise includes the creation of non-clinical development programs, design and supervision of GLP toxicology studies, or support in consultations with European or non-European authorities. Since 2021 she runs her own consulting company in Vienna.
Dr. Matthias Germer
Biotest AG, Dreieich
Vice President Preclinical Research
Dr. René Thürmer
- requested - Expert for Pharmaceutical Quality, Bonn, Germany
24-26/06/2024
24-26/06/2024
Day I-IIII: 09:00 am - 5:00 pm - Online training
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.
All three course days can be booked individually, i.e.
individual course day of your choice
(please contact us to book)
€ 1.190,- (+ VAT)
Two course days
€ 1.890,- (+ VAT)
Alle three course days including online test
€ 2.590,- (+ VAT)
OPTIONS
+ Reg. requirements (day I+II)
+700,00 €
+ Biopharm. analytics (day I+II+III)
+1.400,00 €
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Your booking advantage: You book the regular seminar and the e-learning in addition. The price of the e-learning is reduced by € 50.00 (€ 340.00 instead of € 390.00 plus VAT).
340,00 €
e-Learning: CTD Module 3
, online
Your booking advantage: You book the regular seminar and the e-learning in addition. The price of the e-learning is reduced by € 50.00 (€ 340.00 instead of € 390.00 plus VAT).
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.
All three course days can be booked individually, i.e.
individual course day of your choice
(please contact us to book)
€ 1.190,- (+ VAT)
Two course days
€ 1.890,- (+ VAT)
Alle three course days including online test
€ 2.590,- (+ VAT)
OPTIONS
+ Reg. requirements (day I+II)
+700,00 €
+ Biopharm. analytics (day I+II+III)
+1.400,00 €
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Your booking advantage: You book the regular seminar and the e-learning in addition. The price of the e-learning is reduced by € 50.00 (€ 340.00 instead of € 390.00 plus VAT).
340,00 €
e-Learning: CTD Module 3
, online
Your booking advantage: You book the regular seminar and the e-learning in addition. The price of the e-learning is reduced by € 50.00 (€ 340.00 instead of € 390.00 plus VAT).
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (a single day of your choice = 1.190€ plus VAT) - for booking, please contact us!
After Day 1, you will be familiar with the specialties of galenic development process technologies and you will know what to look out for in process changes and comparability studies.
After day 2, you will be aware of critical quality parameters of biologics and biosimilars and know the challenges of the non-clinical program.
After day 3, you will have gained expertise in method validation, stability testing and specification writing.
Following Day 3, you will receive the access data for the optional online test for learning success control by e-mail.
09:00
Dr Josef Gabelsberger
10:30 Coffee break
11:00
Dr Monika Geiger
12:30 Lunch break
13:30
Dr. Jörg Engelbergs
15:00 Coffee break
15:15
Dr Jörg Engelbergs
17:00 End of day 1
09:00
Dr Sonja Matt
11:00
Dr Anika Schröter
12:00 Lunch break
13:00
Dr Anika Schröter
14:00
Dr Sonja Matt
14:45 Coffee break
15:00
Dr. Anika Schröter
15:30
Dr Sonja Matt
17:00 End of day 2
09:00
Dr Matthias Germer
10:15 Coffee break
10:30
Dr René Thürmer
12:00 Lunch break
13:00
Dr Matthias Germer
14:00
Dr René Thürmer
14:45 Coffee break
15:00
Dr René Thürmer
16:30 Q&A day 3
17:00 End of Online Training
All three course days can be booked individually (a single day of your choice = €1,190 plus VAT).
For booking, please contact us!
This course has been audited and accredited by the independent PharmaTrain Federation (www.pharmatrain.eu).
In this context, one pillar is the achievement of sustainable learning success.
For this reason, we offer you the opportunity to take an optional online multiple-choice test if you book all three days of the course.
This can be completed online up to 14 days after the event in order to document the knowledge acquired with a special certificate.
Completing the online test is optional. You will receive a certificate of attendance regardless of this.
This seminar is the basic module of our Development Expert Biologics qualification programme.
The course concept:
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.
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Teilnehmerstimmen aus Februar 2016
Sehr viele interessante und relevante Vorträge für meine tägliche Arbeit, gute Themenauswahl - rundum Übersicht; sehr gute Organisation, praktischer Nutzen, sehr gute Vortragende, gute Aufteilung; Möglichkeit der Zwischenfragen und hilfreiche Beantwortung; kompetente Referenten, Vielfalt von Themen
Sehr gute und detaillierte Präsentationen zu aktuellen Themen, die fachliche Diskussion mit den Dozenten; Ich würde jederzeit diese Veranstaltung weiter empfehlen
Dr. Christin Selent-Stier
Kleine Gruppengröße, dadurch gute Netzwerkmöglichkeiten, sehr gute Abdeckung des breiten Fachgebiets durch ausgewählte Themen; Als Lehrgang für Start-ups die sich mit der frühen klinischen Entwicklung von Biologicals befassen, sehr empfehlenswert!
Dr. Michaela Arndt
NCT Nationales Zentrum für Tumorerkrankungen
Teilnehmerstimmen aus Februar 2017
Vermittelt sehr gut die Säulen von der Entwicklung bis zum Markt
Florian Waldmann
Senior Manager Quality Control, Formycon AG
Empfehlenswert für Biosimilar CMC
Dr. Christian Panke
Projektmanager, Alvotech Germany GmbH
