Building a Core Labeling Process - Drug Information Association

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Establishing Operating Mechanisms: The Quality Procedure/SOP • Examples of GLC Responsibilities: – AApproving i new or revised i d CCDS content t t by b documenting d ti their th i approval l in writing or electronically – Assigning deadlines for local/regional labeling submissions – Reviewing Key Country implementation of CCDS into labeling • US, Canada, EU, Japan ( keeping an eye to label harmonization) – Review performance of labeling implementation – Reviewing overall performance of the labeling process/system Drug Information Association www.diahome.org 7 Establishing Operating Mechanisms: The Quality Procedure/SOP • Consider establishment of Regional Coordinators Role – Canada – European Union – Latin America – Asia Pacific • Roles and Responsibilities of the Regional Coordinator – Assure accurate implementation of CCDS into country labeling • Works with QPPV, Region Medical and PV – Coordinate submission time lines with regional RA – Responsible for tracking of submissions in their regions – Works with local MOH on responses' back from labeling submission – Communicate country specific requirements Drug Information Association www.diahome.org 8 10/20/2011 4
Establishing Operating Mechanisms: The Company Position • Establish the format and style of your CCDS document – Mandatory and non- non mandatory content – Instructional text ( notes and comments that may assist with implementation) • Establish the companies position regarding the following – Warnings and Precautions – Establishment of ADRs both based on clinical trial experience and post marketing, what is the company’s threshold – Pregnancy and Lactation – Drug interactions – Class labeling – Other Drug Information Association www.diahome.org 9 Establishment of Operating Mechanisms : Scientific Support for the Labeling submission • Establishment of justifications documentation (e.g. in Clinical Overview format) – A separate document that supports all (mandatory) labeling statements intended to be incorporated into local labeling – This support is inclusive of clinical data, Pharmacovigilance data, and peer reviewed literature. – eCTD modular format is recommended (regions can cut and paste into their own eCTD labeling submission • Establishment of signal detection and regular meetings with Pharmacovigilance – How will the CCDS and labeling organization operate with the Pharmacovigilance organization? Drug Information Association www.diahome.org 10 10/20/2011 5
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Page 7: Sustainability • Regulatory Label

Building a Core Labeling Process - Drug Information Association

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