Global Labeling Process Design and Evaluation May 22-23, 2013 PERI Training Facility ~ Arlington, Virginia

Transcription

1 Global Labeling Process Design and Evaluation May 22-23, 2013 PERI Training Facility ~ Arlington, Virginia Wednesday, May 22, :30 8:00 AM Registration and Continental Breakfast 8:00 8:15 AM PERI Welcome Address Marian Selby Course Manager Pharmaceutical Education and Research Institute, Inc. (PERI) 8:15 10:30 AM Global Labeling Process: Key Features and Performance Criteria Impact of EU Pharmacovigilance Guidelines Course Director President, Pharmaceutics LLC Managing Director, Pharmaceutics Labeling Services LLC Managing Director, Pharmaceutics Consulting and Training LLC 4 Managing requests for labeling decision making Labeling decision making: - Process - Selection and empowerment of deciders Types of labeling decisions Recording and issuing labeling decisions Prioritization: Process, criteria, issue resolution Tracking, auditing, reporting - Impact on process stringency - Need for tracking and self-auditing - Impact on the interface with Pharmacovigilance - Process and nomenclature 10:30 10:40 AM Refreshment Break 10:40 11:00 AM Familiarization With Course Materials 11:00 AM 12:30 PM Scope of tye Labeling Process and Request Management 5 6 Risks associated with suboptimal request management Organizational settings associated with increased risk Who should be allowed to request decision making? Designing the interface with the safety evaluation process Scope of request management; where should requests from the medical labeling process and other processes converge? 12:30 PM 1:15 PM Luncheon 1

2 Wednesday, May 22, 2013 continued 1:15 3:00 PM Process Scope and Request Management (cont.) 7 Initial request evaluation and clarification; getting endorsement for requests to proceed to decision making; proper ways to stop requests Request registration and numbering to ensure traceability, and other means of tamper-proofing the process A simple tool for robust request management on process management and required tools Can I follow the same request management process at headquarters and at the affiliate? 3:00 3:10 PM Refreshment Break 3:10 5:00 PM Decision Making Principles, Settings, Process and Documentation Types of labeling decisions For what do we need formal decisions and decision records How to deal with decisions NOT to change labeling How to ensure decisiveness Designing decision making committees and decision making rules Decision making in special situations How to record decisions and distribute/archive the documentation (e.g. on training requirements) Can I follow the same process at headquarters (for Core labeling decision making) and at the affiliate level? 8 Thursday, May 23, :30 8:00 AM Continental Breakfast 8:00 10:00 AM Issuance of Decisions and Feedback During Implementation 9 Issuance as trigger for downstream request management Bundling various decisions for issuance Deciding which decisions should be tracked 2

3 Implementation and reporting obligations for affiliates (rules, tools, what and how specifically to report Implementation and reporting obligations for supply chain functions Implementation and reporting obligations for other outlets (e.g., websites, compendia, labeling printed for sales force 10:00 10:10 AM Refreshment Break 10:15 12:15 PM Issuance of Decisions and Feedback During Implementation (cont.) 10 Rules for involving upstream functions in decision making about content, format and timelines How to decide whether local implementation is sufficiently consistent with core labeling Rules that define deviations that require prior approval by upstream functions Handling implementation in deferred-action markets Principles of implementation tracking 12:15 2:15 PM Luncheon + Opportunity to Discuss Practical Experiences with Implementation Tracking and an Electronic Implementation Tracking System 3

4 Thursday, May 23, 2013 continued... 2:15 3:00 PM What to track, What to Audit? 11 How to manage process performance? Contributions of tracking and auditing to process performance Principles and milestones for implementation tracking; who should be responsible for tracking what; the complexity of tracking Principles and targets of auditing Analysis of findings, reporting and interventions 3:00 3:15 PM Refreshment Break 12 3:10 4:10 PM Putting Everything Together The specific system we created - Overview of all SOP modules, policies, forms/templates and other documents used/created during the seminar Process and policy areas not yet covered Discussion of approaches for still open areas, as decided by the audience Take-home elements and need for customization to meet a specific company s needs Cautionary advice on strategies to improve an existing labeling system - Cardinal mistakes when changing existing labeling systems A final look at the EU GPV guidelines 4:10 5:00 PM Evaluating an Existing Labeling System & Wrap up 13 Types of diagnostic approaches and their value Walk through a system self-evaluation questionnaire provided by the instructor 5:00 PM Adjournment 4

5 CONTINUING EDUCATION CREDIT Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit both the Continuing Education Application form and the program evaluation directly to a PERI on-site coordinator. A continuing education certificate will be distributed to you within three weeks of this program. Pharmacy Continuing Education Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is # L03-P. 1.4 continuing education units (CEUs) are available for this program. Initial Release Date: 5/22/2013. This is an application based CPE Activity. Continuing Medical Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. designates this educational activity for a maximum of 14 AMA PRA Category 1 Credit(s) TM. Physicians should only claim credit commensurate with the extent of their participation in the activity Pharmaceutical Education & Research Institute, Inc. (PERI) All Rights Reserved 5