s Presented by Dr Ennis H Lee, Senior Partner, TranScrip 14 June 2016
Monitor for changes in regulations Regulatory Authority websites Pharmaceutical industry bodies Pharmaceutical press Use global subsidiaries An Indegene and TranScrip alliance Private & Confidential 2
Get involved in shaping new regulation Review legislation and guidance documents Comment directly to Regulatory Authorities Comment via industry bodies Attend Regulatory Authority briefing meetings An Indegene and TranScrip alliance Private & Confidential 3
Communicate change Up - Senior Management Down Staff / Contractors Sideways Global subsidiaries Licence partners Vendors An Indegene and TranScrip alliance Private & Confidential 4
Updating of EU PV Legislation Extensive changes to EU PV regulation started with legislation implementation in 2012 Major changes to the requirements for a company PV System were needed Change is still ongoing and will be for some time IT systems to support PV still not operational Resource is a major challenge for all An Indegene and TranScrip alliance Private & Confidential 5
Challenges of the EU legislation change Change in the definition of ADR Requirements to collect AEs medication errors, overdose, abuse, etc. New signal management needs New format safety documents DSUR, EU-RMP, etc. Pharmacovigilance System Master File Requirements for global safety data, documenting global PV vendors, Partner agreements, etc. Audit requirements and documentation An Indegene and TranScrip alliance Private & Confidential 6
Global PV System One global assessment of drug safety Global standards, labelling, etc Data from global company sources Global company databases Actions in one country affect all other countries Document pharmacovigilance practice and standards An Indegene and TranScrip alliance Private & Confidential 7
Task Forces Get buy-in from and set up feedback mechanism to senior management Appoint an influential chair and a lead for each function Charter of goals and activities Manage an action list and costings Site for all documentation Feedback from all functions on how changes will influence their practice, if at all Expect challenges! An Indegene and TranScrip alliance Private & Confidential 8
Assess change needed Assess regulatory and guidance documents one function leading: Assess changes needed Consider impact on other countries Will IT systems help? Knock-on effects to Partners, Vendors, etc Allocate actions for each function An Indegene and TranScrip alliance Private & Confidential 9
Make an implementation plan What needs to change What When By whom Transition plan Communication plan Costings for change Feedback for senior management An Indegene and TranScrip alliance Private & Confidential 10
Controlled documents Review all current controlled document for changes Appoint a lead for all updates and new documents Set timelines Mechanism to roll-out to relevant staff groups Assess compliance with training real-time Set criteria to measure effectiveness and measure An Indegene and TranScrip alliance Private & Confidential 11
Training and roll-out Communication plan Explain need and how change will be managed Assess training needs globally by function Set challenging but realistic goals Management oversight of compliance Set Goals and Objectives for staff globally Ongoing CPD requirements An Indegene and TranScrip alliance Private & Confidential 12
Implementation Set dates for changes Regularly assess progress against the plan Document change and inform Regulatory Authorities of changes as required Regularly feedback Senior management (reports) Staff globally (newsletters) Minimise confusion! An Indegene and TranScrip alliance Private & Confidential 13
Audit, review and update Internal audit plan to review new processes and practices as part of implementation Audit by both process and function Regularly feedback to senior management Manage a CAPA process to ensure compliance with required changes Update processes and repeat the cycle of change management and audit An Indegene and TranScrip alliance Private & Confidential 14
The challenges of Pharmacovigilance! An Indegene and TranScrip alliance Private & Confidential 15