Manufacturer Challenges. March 2017. 2. Manufacturer . Challenges. Agenda today. - . Background. - Core team. - SharePoint site. - Readiness. - Challenges Affiliates. - . Best practice. ©2016 |. . EU FMD. ID: 628835
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30th March 2017
EU FMD
Manufacturer Challenges
Slide2March 2017
2
Manufacturer
Challenges
Agenda today
-
Background- Core team- SharePoint site- Readiness- Challenges Affiliates- Best practice
©2016 |
EU FMD
Slide3Why are we doing FMD?
March 2017
3
Patient safety and compliance
:
Falsified medicinal products are a serious threat to the health and safety of patients around the world. They range from drugs with no active ingredients to those with dangerous impurities. They can be copies of branded drugs, generic drugs or over-the-counter drugs.
Patient health and safety is of the utmost importance to the pharmaceutical industry. Protecting our patients, our people, our brand and our supply chain is one of our main goals.©2016 | EU FMD
Slide4Legal Requirements – why we must do it
March 2017
4
©2016 |
EU FMD
EU Falsified Medicines Directive 2011/62/EU (EU FMD of June 2011) introduces
obligatory ‘safety features' (a unique identifier and an anti-tampering device) as part of the outer packaging of prescription medicinal products;Delegated Regulation EU Safety Features publication 9 February 2016Implementation: + 3 years = 9 February 2019Waiver countries have additional +3 years/2022 (Italy, Greece, Belgium)EU Safety Features required at saleable unit:Anti-Tampering Device (ATD)Unique Identifier (UI), utilizing 2D-Matrix barcodePan European Verification SystemInteroperableCost-EffectiveBlueprint Systems
Slide5Area Core Team AbbVie
March 2017
5
Quality Assurance (QA)
Gert-Jan van
Diest (EU Safety Features Program Manager)Governmental Affairs (GA)
Ludovic Lacaine & Florentin ScarlatArea Regulatory Affairs (RA) Ingela Frick, Marika Sebre Regulatory Affairs (RA) Lynsey Flitton, Viktoria GrahnenBusiness Intelligence (BI) Vasilis Zormpaidis (LEx Roadmap)Finance (Fin.) Marine Hoang-HaasLabel Mgmt. (GLM) Georgina GalLegal / General Counsel Miguel EstebanSupply Chain IT
René KronenburgDistribution (D&L) Damien Gannon
Communication
Maureen
Goudriaan
©2016 |
EU FMD
Slide6EU Program SharePoint
Share Best Practices
Template documents & presentation material
Store project deliverables and other important program info
Communication
Share latest news
March 2017
©2016 | EU FMD
6
Slide7Manufacturing Site readiness
March 2017
7
Serialization
Tamper Evidence
Features
©2016 | EU FMD
Slide8IT Readiness
March 2017
8
©2016 |
EU FMD
Slide9Regulatory Readiness
March 2017
9
Centralized products submission guidance, mock-ups
National product submission guidance and timelines
Artwork/labeling change management
Shared Label Strategy (multi-market packs)Coding requirements (single GTIN standard vs National Codes)Prefixes and Human Readable Information standardsPhase out of the linear barcode ©2016 | EU FMD
Slide10Quality Systems Readiness
March 2017
10
Batch release process for serialized products, role of the QP?
GDP processes to adjust to serialization
IT validation required
Role of the 3PL (Affiliate warehouse, distributor)?(Suspect) falsified medicines incidentsManaging Transition Period 2019 - 2025©2016 | EU FMD
Slide11Organizational Readiness
March 2017
11
Timelines
less than 500 working days left
Resources and Budget
Cross-functional teamsAll departments impactedMaster Data ManagementIDMPCommunication and awarenessLegal aspects (OBP, EMVO, NMVO, NTA, MAH)Financial aspects: Ramp-Up phase budget 2017-2018Flat-fee cost model >2019
Contributions vs Loans
©2016 |
EU FMD
Slide12Challenges Affiliates
March 2017
12
Still lack of blueprint
selection
Still no NMVO set up
Still no country decision to use GTIN or NTINNeed clarification on when lines will be readyNeed clarification on when mock-ups will be readyWants to understand if they can be allowed to join a local pilotMajority needs to understand why a Stake holder mapping is needed and how to do oneMany affiliates need to market themselves and get a stronger sponsorshipNeed to understand FMD better
©2016 |
EU FMD
Slide13Best practice
March 2017
13
O
versight / transparency of the line-readinessTE
guidance early on Label centre early involvement to plan work-loadNational Products – need for changing packaging material due to adding serialization and TE?Possibility of flexible resources to raise & approve artwork changesPackaging engineering group and Artwork groups close alignment and collaboration.Prepare for the increased workload if monthly numbers increase due to delay in implementation (Dashboard)Close collaboration and transparency with Upper Management and/or Steering committeeInvolvement
from Commercial early on – advocates and usually the ones who pays
©2016 |
EU FMD
Slide14March 2017
14
©2016 |
EU FMD
www.abbvie.com
ingela.frick@abbvie.com
Slide15March 2017
©2016 | EU FMD
15
Slide16
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