2021-12-01 2022-09-02 Hilton Garden Inn Frankfurt City Centre +49 69 269596-0 +49 69 269596-100 Hilton Garden Inn Frankfurt City Centre Weserstraße 43, 60329 Frankfurt Frankfurt, 60329 1.890,- € plus tax Barbara Grossman https://www.forum-institut.com/seminarDetail/19/referenten/22/22_09/22092611-course-scientific-wirting-in-regulatory-affairs_grossman-barbara.jpg Scientific Writing and Reviewing in Regulatory Affairs

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.

Topics
  • Free writing versus regulatory restrictions
  • Writing and reviewing regulatory documents
  • Editing and proofreading documents
  • Package leaflet - regulatory linguistic restrictions and user-friendly writing
  • Good writing skills - example: clinical overviews and summaries
Aims and objectives
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.
Who should attend

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.

Course: Scientific Wirting in Regulatory Affairs

Scientific Writing and Reviewing in Regulatory Affairs

Benefits
  • Live-Meeting in Frankfurt
  • Throughout the days: practical hands-on exercises
  • Package Leaflet and CTD included
  • We are following the IMI quality criteria

Webcode 22092611

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

01. - 02.09.2022

01. - 02.09.2022

Period

Day 1: 10:00 - 17:00(09:30 registrat...

Day 1: 10:00 - 17:00
(09:30 registration)
Day 2: 09:00 - 17:00
Venue

Frankfurt

Frankfurt

Fee
Your contact person

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

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.

Topics
  • Free writing versus regulatory restrictions
  • Writing and reviewing regulatory documents
  • Editing and proofreading documents
  • Package leaflet - regulatory linguistic restrictions and user-friendly writing
  • Good writing skills - example: clinical overviews and summaries
Aims and objectives

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.

Who should attend

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.

Detailed programme

Day 1: 10:00 - 17:00
(09:30 registration)
Day 2: 09:00 - 17:00

10:00 - 10:15

Barbara Grossman

Overview of writing and editing documents
  • Basics of writing and editing - fine-tuning within and across documents
  • Considering the reader

11:00

Barbara Grossman

Continuation: Overview of writing and editing documents
  • Basics of writing and editing - fine-tuning within and across documents
  • Considering the reader

12:45 Lunch break


13:45

Barbara Grossman

Writing and reviewing regulatory documents
  • Target audiences
  • Different approaches for different documents?
  • Corresponding with the authorities
  • Common errors in English that should (or must?) be avoided
  • Prepositions

16:00

Barbara Grossman

Continuation: Writing and reviewing regulatory documents

17:00 End of day one


09:00

Dr Jörg Fuchs

Free writing versus regulatory restrictions
  • Regulatory specifications, suchas QRD requirements
  • Linguistic restrictions due toregulatory specifications
  • Understanding medical conceptsand their correct use
  • Authority requests

10:30 Coffee break


10:45

Dr Jörg Fuchs

How to write a package leaflet in English
  • Patient-friendly languageand volume of text
  • Formatting and typography
  • Use of drug dictionaries
  • Tables and figures; proper English

12:15 Lunch break


13:15

Barbara Grossman

Writing in English for regulatory affairs
  • Aspects of English including punctuation, word order and voice

14:45 Coffee break


15:00

Barbara Grossman

Good writing and reviewing skills in regulatory documents
  • Improving readability includingpractical group exercises 
  • In terms of language, consideringhow perfect documents need to be
  • Dos and dont's in clinical overviewsand summaries
  • Proofreading essentials including: Final checks - not just a spell check Practicalities, tips and tools

17:00 Seminar end


More information

Your benefits of this seminar

  • Two highly experienced speakers
  • Throughout the days: practical hands-on exercises in the conference room
  • Practical examples regarding English wording in package leaflets and clinical overviews and summaries

e-Learning: Common Technical Document & eCTD

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).

E-learning principles

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.

How to book the e-learning programme in addition to the seminar

Please register for the seminar "Scientific Writing and Reviewing in Regulatory Affairs" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €490 + local VAT rather than €590 + local VAT).

This distinguishes our events

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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Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

Details
More on our quality criteria

Testimonials

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