Past Event
日にち
March 22nd - 24th
Location
Virtual
DIA MASC
Speakers and Posters
22年3月 | 11:30 AM EDT
Session 2 Track 2: The Impact of the COVID-19 Pandemic on Medical Writing: What 2020 Taught us About the Way we Plan, Author, and Deliver Scientific Communications and Regulatory Submissions
David Meats: Synchrogenix-Associate Director-Global Submissions-Regulatory Services Manager, Ruggero Galici PhD: Pfizer, Inc. Associate Director-Medical Writing, Demetrius Carter, MBA, PMP, RAC-US: Synchrogenix, A Certara Company-SVP, Regulatory Services, Adesh Saxena, PhD: Pfizer, Inc. Director, Submission Medical Writing |
The COVID-19 pandemic altered the way the public lives and works. This session explores challenges and solutions implemented by the medical regulatory and scientific publications industry during the ongoing COVID-19 pandemic, thus far. Panelists will share their experience and thoughts throughout moderated questions and live interactions with the audience. At the beginning of the session, data from a survey will be presented to stimulate discussion. Session 2 Track 2: The Impact of the COVID-19 Pandemic on Medical Writing: What 2020 Taught us About the way we Plan, Author, and Deliver Scientific Communications and Regulatory Submissions
22年3月 | 1:45 PM EDT
Session 3 Track 2: Guiding Journal Targeting: Shooting for the Moon may Leave you Lost in Space
Jennie Jacobson, PhD: Cadent Medical Communications, a Syneos Health Company Medical Director, Diane Cleverley, PhD: Synchrogenix, a Certara Company Senior Regulatory Writer, Meera Kodukulla, PhD: Astrazeneca Head, Scientific Publication, Jennifer Zimmer, MD Eli Lilly and Compay Senior Medical Advisor, Alzheimer’s Disease Team |
The saying ‘Shoot for the moon, even if you miss you may land among the stars’ does not apply to targeting journals for biomedical publications. Aiming high sounds good to authors and companies who want the highest status journal possible for their manuscripts, but may be the beginning of a costly cycle of rejection and resubmission that significantly delays publication. As medical writers, what is our role in helping publication stakeholders to target realistic journal targets? Session 3 Track 2: Guiding Journal Targeting: Shooting for the Moon may Leave you Lost in Space
On Demand 3 Track 2: Using Type 9 NDA Classification to Accelerate Multiple Approvals for Your Drug Product
David Meats: Synchrogenix, Associate Director, Global Submissions, Regulatory Services Manager, Elaine Taylor: Synchrogenix, a Certara Company, Vice President, Regulatory Strategy and Policy, Vibha Kumar: Synchrogenix, a Certara CompanyAssociate Principal Regulatory Writer |
This session describes FDA’s policy regarding US NDA classification codes, Types of NDAs, and Type 9 NDAs in specific. Session attendees will learn the submission process of Type 9 NDA submissions compared to other submission types. Furthermore, the benefits and risks associated with the Type 9 NDA process will be discussed. After watching this session, join the speakers for a LIVE Question & Answer Session on Tuesday, March 23 1:40-2:00PM. You can leave your questions in advance in the Chat. On Demand 3 Track 2: Using Type 9 NDA Classification to Accelerate Multiple Approvals for Your Drug Product
