Webcode 22092611
Barbara Grossman
Hawkeye Medical Limited Medical Writing & Consultancy, Great Britain
Barbara Grossman has a passion for proofreading, quality control, and education. She started Hawkeye Medical Limited, a medical writing and consultancy business, after working for a medical publishing company and then a contract research organisation, where she built up and managed its medical writing group. Barbara runs professional development training for companies and educational institutions. She has had many roles in the European Medical Writers Association (EMWA): workshop leader since 2001, Treasurer 1998-2005, member of the Education Committee 2010-2018, Education Officer 2014-2016. She was awarded an EMWA fellowship in 2005 and was EMWA President for 1 year until May 2020. In addition, Barbara is an Associate Editor of Medical Writing, EMWA's journal.
More information please click here.
Dr. Jörg Fuchs
PAINT-Consult®, Jena
Managing Director, User Testing Consultant
Dr. Jörg Fuchs is the professional who stands for user-friendly medical information and readability tests. He is founder and head of PAINT-Consult® - a company specialised in readability testing, usability tests, medical information, research studies and more, across the field of regulatory affairs. Having completed his pharmacy studies at Greifswald in 1996, he immediately applied himself to conducting research into the improvement and testing of patient information leaflets. This work led to a doctorate at the Humboldt University of Berlin and, since 2005, the research has continued at the Department of Drug Regulatory Affairs in the University of Bonn.
More information please click here.
01. - 02.09.2022
01. - 02.09.2022
Day 1: 10:00 - 17:00(09:30 registrat...
Day 1: 10:00 - 17:00
(09:30 registration)
Day 2: 09:00 - 17:00
Frankfurt
Frankfurt
Event - 1.890,- € plus tax
The fee includes a comprehensive online documentation and a certificate
Event - 1.890,- € plus tax
The fee includes a comprehensive online documentation and a certificate
Dr. Henriette Wolf-Klein
Head of Department
+49 6221 500-680
h.wolf-klein@forum-institut.de
After completing this online seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
Practical examples regarding the English wording in package leaflets and clinical overviews and summaries complete this seminar.
This seminar is intended for all those working in regulatory departments in the human and veterinary pharmaceutical and medical device industries with basic experience in writing, reviewing or proofreading regulatory documents in English.
Participants should have good English reading and writing skills and a basic knowledge of regulatory documentation.
10:00 - 10:15
Barbara Grossman
11:00
Barbara Grossman
12:45 Lunch break
13:45
Barbara Grossman
16:00
Barbara Grossman
17:00 End of day one
09:00
Dr Jörg Fuchs
10:30 Coffee break
10:45
Dr Jörg Fuchs
12:15 Lunch break
13:15
Barbara Grossman
14:45 Coffee break
15:00
Barbara Grossman
17:00 Seminar end
Do you lack CTD/eCTD expertise (including CMC know how for CTD module 3)? Then, we would recommend the 'Common Technical Document & eCTD' e-learning programme.
This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.
It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).
The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts Lidia Cánovas and Michael Schaub shares their expertise with you. You can also download and print the corresponding presentation documents.
Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.
Once you have completed the four modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.
Overall impression: 100 % of the participants' feedback was very good or good (April 2018)
Course content: 100 % of the participants' feedback was very good or good (April 2018)
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This was well received by the participants in February 2020
It does met my expectiations!
Dr. Shuofei Cheng
MegaPart GmbH
Interactive and informative, entertaining, to too crowded.
Wolfgang Schacke
United BioSource Corporation (UBC)
Editing and reviewing English
Barbara was awsome
Interesting and helpful
Ideas, suggestions to improve readability and consistency is important. Adn be careful about merged texts and reread the document
