CTD Module 3 Workshop

The workshop combines:

Live Training sessions- where we go over specific sections of Module 3 and discuss what is needed to populate it and who to assign from our teams
Recorded training sessions from the CMC Essentials Training Course (See here)- covers different topics in CMC Development, if needed for extra background and reference
Private sessions- each team gets assigned a dedicated weekly session to discuss their progress and questions (under confidentiality.

Participation Fee:

The workshop is available as a public cohort (open to different teams to join), or private (recommended for teams of more than 3 people)

Public cohort: $2800 /seat- PLEASE REGISTER INTEREST TO GET NOTIFIED OF NEXT COHORT

Housekeeping
Please indicate the project's Development stage*

Proof of concept / Tox studies (Preclinical)Planning to start Phase 1 clinical trials / FIHClinical trials ongoing (Phase 1-2)Approaching end of Phase 2 / starting Phase 3 this yearPhase 3 ongoing, preparing for NDA/BLA/Process validationProduct is in the market (interested in continual improvement)Other (please elaborate in comments field below)
Please indicate your Regulatory status:*

No formal submission prepared to dateEarly submissions available (INTERACT, Pre-IND, Scientific advice, etc)Module 3 available / submittedOther (please elaborate in comments field below)
Our team has in-house:

Development specialists and wet lab workersRegulatory affairsManufacturing operationsProject managers (CMC or other)Quality assuranceClinical opsOther
Will you be interested in the public or private workshop?
Participant Information

A participant is the primary point of contact for a team.
Name*

First NameLast Name
Phone Number
Email*
example@example.com
Company headquarters in:

Street Address

Street Address Line 2

CityState / Province

Postal / Zip CodeCountry
Workshop participants located in:

Street Address

Street Address Line 2

CityState / Province

Postal / Zip CodeCountry
Paticipant(s) Job title
Company Name
Any additional comments or information you would like to share?
Should be Empty:

Housekeeping