Join the NJ/NY Chapter for an overview of the ICH M4Q(R2) revision which will be shared by an ICH expert working committee member. The modernization of M4Q(R1) will allow for a better global understanding of the CTD, enable greater regulatory convergence and harmonization and decrease redundancy. The guideline will provide guidance on the location of information supporting multicomponent and/or complex products and will facilitate leveraging advances in digital tools, data management and standardization. The organization and positioning of information for Modules 2 and 3 will be discussed. The M4Q(R2) revision will combine innovation, efficiency and global harmonization to help patients receive treatment faster. Join us for an update on the latest plans for the ICH M4Q(R2) CTD guidance.
Registration Fees & Deadlines
Member $0 | Nonmember $25
Speakers
Rudy Peeters
Johnson & Johnson Innovative Medicine
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.