Management of ODS Regulatory Referenced Deliverables

Management of ODS Regulatory Referenced Deliverables

Project Scope 

Project Scope 

The scope of this project is to identify a primary and back-up representative for each PHUSE regulatory referenced deliverable that will:

  • review updates to regulatory documents where PHUSE deliverables are referenced to ensure they are in alignment

  • identify any updates that are required due to updated regulatory documents

  • organise the updates, including addressing feedback from PHUSE members

  • discuss the updates with the ODS Working Group Leads to agree on the updates

  • oversee the updates and publishing of PHUSE deliverables

  • commit to serving as a representative for two years.

The project team will meet quarterly with the ODS Working Group Leads to discuss potential updates and their timing to avoid burdening the project team members and the regulatory authorities in reviewing the updated deliverables.

Project Leads 

Email 

Project Leads 

Email 

Janet Low, Merk

janet_low@merck.com

Christine Rossin, Pfizer

Christine.Rossin@pfizer.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global

Regulatory Referenced Deliverables

Representatives

Email

Regulatory Referenced Deliverables

Representatives

Email

ADRG

Sumit Pradhan, Syneos Health

 

Pradnya Bharambe, Fortrea 

sumit.pradhan@syneoshealth.com

PBharambe@ultragenyx.com

BDRG

Dipen Kachhiapatel, Syndax

 

Mathura P Ramanathan

dipenkachhia745@gmail.com

mprnathan@gmail.com

cSDRG

Zhaojuan Meng, Sanofi

 

Suresh Yenishetty, IQVIA

Zhaojuan.Meng@sanofi.com

suresh.yenishetty@iqvia.com

iADRG 

Christine Rossin, Pfizer

 

Kiran Kundarapu, Loxooncology

Christine.Rossin@pfizer.com

kkundarapu@loxooncology.com

icSDRG

Michael Wise, Edwards

 

Misty Michelle Odle, Eli Lilly 

michael_wise@edwards.com

odle_misty_m@lilly.com

SDSP

Venkat Rajesh Datla, Genmab 

Priyanka Pollarine, Biogen

veda@genmab.com

priyanka.pollarine@biogen.com

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