- Online training -
Webcode 23032451
Dr. Christina Juli
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Head of CMC Management CMB Dr. Christina Juli studied pharmacy at the University of Würzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined theratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working at the manufacturing site for biopharmaceuticals of Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of CMC Management CMB, she focuses on the CMC development for biologics and is responsible for the definition compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group
Dr Galina Senchukova
CSL Behring Biotherapies, Moscow, RUSSIA
Head of Product Market Authorization and Quality Assurance, PhD in Pharmaceutical Chemistry. 20 years in regulatory area in total: for 6 years - Tutor of Pharmaceutical Chemistry at Pharmaceutical State University (Pyatigorsk, Russia), 9 years of experience in Drug Product development for Russian manufacturers and 6 years - in local batch release quality control; 11 years in Big Pharma RA departments.
Jack Wong
Founder of Asia Regulatory Professsionals Association, Singapore
Over 25 years of regulatory, quality, clinical trial and pharmacovigilance experience in Asia with good knowledge in the field of nutritional, pharmaceuticals, medical devices, consumer healthcare and biological products. Externally, playing a leading role among all the regional regulatory professionals in AHWP (Asian Harmonization Working Party). Being the founder of ARPA (Asia Regulatory Professionals Associations) since 2010 with over 4800 members. Adjunct Lectureship & Visiting Professorship with Nanyang Technological University (Singapore), Tohoku University (Japan), Beijing University (China), Chinese University of Hong Kong (Hong Kong), University of Hong Kong (Hong Kong), Taipei Technical University (Taiwan), University of Sydney (Australia), Dongguk University (Korea)
Prashant Shroff
PharmaLex India Pvt. Ltd., Delhi, INDIA
Prashant Shroff has worked at CDSCO (Zonal office of Indian Govt. Authority) as a Technical Data Associate. He started his professional journey in private sector with Sun Pharmaceutical Ind. Ltd. in 2016 and then he joined Pharmalex India Pvt. Ltd. Currently, he is working as a Manager for the regulatory submissions and CMC documentations. In his career, he has well-versed experience for the Indian registration procedures for drug products as well biologicals covering regulatory strategy throughout the life cycle management, documentation, pharmacopoeial compliance, labelling, package inserts etc.
anytime
anytime
1st March, 7th March, 15th March, 22...
1st March, 7th March, 15th March, 22th March 2023
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,250 € zzgl. MwSt.
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
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.
195,00 €
e-Learning: CTD Module 3
, 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 - 1,250 € zzgl. MwSt.
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
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.
195,00 €
e-Learning: CTD Module 3
, 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
Four live webcasts à 2 hours every week in March 2022: CMC requirements in China, India, Japan, South Korea and Russia/EAEU. Meet our four experts to get an update on the current requirements in the different regions and discuss your individual issues with them. You are interested in one webcast only or a group account? Contact us!
During this webcast series you will learn about the specific CMC requirements in China, India, Japan/South Korea and Russia/EAEU.
Four (local) experts will share valuable information regarding
10:00 Welcome, expectations, introduction round
10:10
Jack Wong
12:00 Summary and outstandig questions
12:15 End of webcast
10:00 Welcome and introduction
10:10
Dr Christina Juli
12:00 Summary and outstandig questions
12:15 End of webcast
10:00 Welcome and introduction
10:10
Prashant Shroff
12:00 Summary and outstandig questions
12:15 End of webcast
10:00 Welcome and introduction
10:10
Dr Galina Senchukova
12:00 Summary and outstandig questions
12:15 End of webcast series
You are working with affiliates or external partners in MENA?
Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt) with you - webcasts scheduled weekly in January 2023.
For more information visit our website using the webcode 23012450.
You are working with affiliates or external partners in Latin America?
Three (local) experts will share their in-depth knowledge on CMC requirements in this region with you (focus Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR (Central America and Caribbean) - webcasts scheduled weekly in April/May 2023.
For more information visit our website using the webcode 23042453.
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.
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
This online conference addresses digitalisation of labelling, patient-friendly labelling and safety labelling in the reg...
Learn the essentials of the MDR and how to navigate around the legislation and to apply it.
Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on...
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chan...
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
This whitepaper describes what you need to keep in mind when it comes to specific Japanese CMC requirements for marketin...
Details
This whitepaper describes the principles of post-approval change management protocols (PACMP) and the related guideline ...
Details
