Danish Medical Writing Network: FDA Advisory Committee meetings
We will learn about FDA Advisory Committee (AdComm) meetings and the role of the medical writer.
During this afternoon we will learn about FDA Advisory Committee (AdComm) meetings and the role of the medical writer. Knowledge about these special FDA meetings is relevant for many pharma companies because all submissions for marketing approval of drugs in the US could be subject to an FDA AdComm. Medical writers often play a pivotal role in the preparation of the meeting material and in supporting the smooth execution of AdComms. Our guest speakers from the consulting company 3D communications will share their vast experience from supporting pharma companies with FDA Adcomms, and our guest speaker from Novo Nordisk will share insights from a recent FDA AdComm from the medical writer perspective. Afterwards, there will be time for questions and discussion groups. Here, you can share and discuss experiences with your fellow medical writers.
Speakers:
- Michelle Zucatti and Cara O'Neill, 3D communications
- Cristina Valacca and Swantje Christin Häger, Medical Writing Specialists at Novo Nordisk and part of the Icodec FDA AdComm in May 2024
Please note, since we are paying IDA Conference for the venue and catering, we have decided to include the following fees:
- Non-members of the network can join the meeting and pay a fee of 200 DKK
- No-show fee: 100 DKK.
- Cancellation fee after 26th February: 100 DKK
The fees will be handled by IDA.
Parking:
IDA Conference has parking spaces right outside the conference center, which must be paid for separately through the Easy Park or the APCOA Flow app. Please be careful when selecting the area code as they differ depending on where you park in the parking lot.
Should you have any questions regarding registration and membership, please contact IDA by filling in this form: https://kontakt.ida.dk/Henvendelser/formular/38
We are looking forward to seeing as many as possible for this exciting afternoon with our intriguing presenters.
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