Scientific ENGLISH Writing and Reviewing in Regulatory Affairs

Detailed programme

Day 1: 10:00 - 17:00
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session

10:00 Introduction round using the Zoom whiteboard

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 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, such as QRD requirements
• Linguistic restrictions due to regulatory specifications
• Understanding medical concepts and their correct use
• Authority requests

10:30 Coffee break

10:45

Dr Jörg Fuchs

How to write a package leaflet in English

• Patient-friendly language and volume of text
• Formatting and typography
• Understanding medical concepts and their correct use
• 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, tense, passive and active voice

14:45 Coffee break

15:00

Barbara Grossman

Good writing and reviewing skills in regulatory documents

• Improving readability including practical exercises such as: Edit, rewrite or leave as is?
• In terms of languages, considering how perfect documents need to be
• Dos and dont's in clinical overviews and summaries
• Proofreading essentials including: Final checks - not just a spell check; Practicalities, Tips and tools

17:00 Seminar end

Detailed programme

Day 1: 10:00 - 17:00
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session

10:00 Introduction round using the Zoom whiteboard

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
...