- Online training -
Webcode 22112454
Cyril van Erp
ProPharma Group, Leiden, The Netherlands
Managing Consultant, Cyril van Erp holds a bachelor for pharmacy and a master in chemical engineering specialized in (Bio)Pharmaceutical product engineering. He has 15 years of international project management position in both clinical and commercial manufacturing environment. This included managing CMC/clinical supply teams to direct pharmaceutical production, relevant parts to dossiers, tech transfers, analytical and process development, budget control and time management. He has worked with PRINCE 2 and PMP project management systems. Most of these activities pertained outsourcing of activities (100kEur to 5MEur) with a dozen of contact manufacturing (CMO) and research organizations (CRO). He has (as a contract giver) worked intensively with CMO/ CRO sites in Italy, Spain, Portugal, France, Ireland, Germany, Japan, Netherlands, India, UK, US and Singapore. He (re)wrote Module 3, IMPD, CTD and IND and (justifications for) variations and answered questions to several notified bodies. He has successfully developed (>5) pharmaceutical generic formulations from initial request from business development to market authorization with only outsourced partners. He has lead (>20) site-to-site technology transfers. He has set up supply strategies and instructions for use for (>50) clinical studies (phase 1-4). This meant supplying ready-to-use medication including release specifications to execute clinical studies including placebo, comparators, 14C, cold chain in small molecules and biologicals. He has worked for Solvay Pharmaceuticals, Abbott, Astellas, DSM-Sinochem Pharmaceuticals and via Propharma Group B.V. (since 2016) for various different pharmaceutical companies.
Frank De Vries
ProPharma Group (Southwood Research), The Netherlands
Director Regulatory Science Europe Frank de Vries has almost 30 years of experience in the life sciences industry, where he held various positions in regulatory sciences as EMEA regional head and in addition has held various roles in business development, commercial and marketing & sales. Prior to joining ProPharma Group in April 2021 the latest position was with AstraZeneca as EU Regulatory Science Lead with successful submissions and approvals of an anchor asset in the hematology/oncology area.
and further speakers
24.11.2022
24.11.2022
09:00 am - 5:30 pm - seminarYou may ...
09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts.
online
online
Veranstaltung - 1.090,- € zzgl. MwSt.
The fee includes course documentation for download and a certificate.
SPECIAL OFFERS
Data requirements in the EU
, 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 €
Stability testing for chemical and biological products 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 - 1.090,- € zzgl. MwSt.
The fee includes course documentation for download and a certificate.
SPECIAL OFFERS
Data requirements in the EU
, 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 €
Stability testing for chemical and biological products 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
Konferenzmanagerin Healthcare
+49 6221 500-652
b.wessels@forum-institut.de
Strategic and operational planning for efficient Marketing Authorisations - Take the chance and discuss your daily business challenges with our experts! The training course will be entirely held in English.
This online seminar provides practical information on the essential project management tasks in Regulatory Affairs (RA) in Europe.
Both the regulatory strategy plan and the operational project and schedule from development to approval are addressed. Professional regulatory documents and optimal communication with the regulatory authorities also play an important role.
At the end of the seminar, you will have acquired regulatory know-how based on many case studies and practical exercises. You will be able to manage your projects more efficiently, both in development and in the approval process as well as postapproval.
This practical seminar is aimed at RA staff who accompany projects or manage them themselves.
The seminar also provides employees from related departments such as Medical Affairs or Development with starting points for efficient cooperation with RA.
The basic principles of drug approval in the EU are assumed to be known.
09:00 Welcome and introduction round
09:15
Cyril van Erp
10:00
Frank de Vries
11:00
Frank de Vries
12:15 Lunch break
13:15
Frank de Vries
14:15
N.N.
15:30
Cyril van Erp
17:00 Summary and outstanding questions
17:30 End of online training
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.
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
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