Challenges and solutions Ronald Schaefer, Project Lead, CEIV Pharma, IATA 24 07 December 2015 - Sydney; CEIV Pharma Workshop
Air freight has lost “market share” to ocean freight Air trade represents ~1.7% of containerized trade weight, after having lost more than 1 point over the last 13 years; average growth in ocean trade far exceeds expansion in air trade Modal shift of 5.4 million tonnes over 13 years corresponds to an average of ~413,000 tonnes shifting to ocean every year Source: Seabury Global Trade Database 25 07 December 2015 - Sydney; CEIV Pharma Workshop
Outbound trade lanes from Asia have strongest shifts Intra-Asia, Transpacific and Asia-Europe have seen substantial volumes shifting to ocean; emerging trade lanes such as LATAM or M. East & S. Asia are relatively less affected Total mode shift since 2000 by weight Note: size of arrows are relative to air trade of region in 2013 2 1 1 7 8 8 40 5 3 7 7 % Regional Share of Total Air Trade Intensity of mode shift (average shift per year): Strong shift to Ocean Moderate shift to Ocean Low shift to Ocean (More than 400,000 tonnes since 2000) (200,000 to 400,000 tonnes since 2000) (less than 200,000 tonnes since 2000) Source: Seabury Global Trade Database 26 07 December 2015 - Sydney; CEIV Pharma Workshop
What is the future of mode shift? Industry expects a moderate shift to ocean, on no specific trade lane; impact of mode shift is expected to be higher for automotive, electronics and machinery goods While perishables have largely shifted to Ocean over the past decade, forwarders do not expect this trend to continue but Pharma will Source: Seabury Global Trade Database 27 07 December 2015 - Sydney; CEIV Pharma Workshop
What factors will be driving mode shift? Industry believes transportation cost has been and will remain the number one factor; shippers and forwarders alike place reliability and environment next in importance Reliability and Operations becomes two important deciding factors to shift mode after Transportation cost for both shippers and forwarder 28 07 December 2015 - Sydney; CEIV Pharma Workshop
What factors will be driving mode shift? Industry believes transportation cost has been and will remain the number one factor; shippers and forwarders alike place reliability and environment next in importance Reliability means a better temperature control through aligned standards and procedures as well as skilled staffs Source: Seabury Global Trade Database 29 07 December 2015 - Sydney; CEIV Pharma Workshop
Background: Pharmaceutical Product Logistics The pharmaceutical industry has relied heavily on the airline industry for its speed and efficiency but air cargo’s share of global pharmaceutical products transport has dropped Pharma air cargo growth; 2008-2018 HOWEVER in % 12 6 Air cargo’s share of global pharmaceutical products transport (in %) 2008-2013 2013-2018 17 Over the past 10 years, air carriers, 11 handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative and niche market. 2000 2013 Source: Pharmaceutical Commerce 30 07 December 2015 - Sydney; CEIV Pharma Workshop
Air Cargo Industry Concerns and Challenges Increasing shift in pharmaceuticals transported by sea due to air cargo challenges More than 50% of all temperature excursions occur while the package is in the hands of airlines/airports Temperature deviation denature the product, render it worthless and be harmful to the health of the patient Products can be lost, scrapped, returned leading to significant costs Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain Annual product losses between US$2.5-12.5 billion due to various The use of air-mode transportation is re- reasons including temperature considered unless industry partners excursions during transport and ensure quality services shipping. 31 07 December 2015 - Sydney; CEIV Pharma Workshop
Air Cargo Industry Concerns and Challenges Temperature Excursions – Where do they occur? Low Risk Medium Risk High Risk Source: Expeditors 32 07 December 2015 - Sydney; CEIV Pharma Workshop
Air Cargo Supply Chain Challenges From origin to destination pharmaceutical products can be exposed to different climates +35°C -10°C +35°C -10°C 33 07 December 2015 - Sydney; CEIV Pharma Workshop
Air Cargo Supply Chain Challenges The process is quite complex and shippers have difficulties to identify stakeholders that meet standards and regulations Example of Flow from BRU to SYD Shipper Forwarder X Forwarder Y Consignee BRU SYD Pick-up In Out In Out In In Out BRU out SIN in out SYD in In Out Airline BRU – SIN - SYD Ground handler BRU Ground handler SYD 14 milestones from start to end. HOW CAN YOU MANAGE THIS ? 34 07 December 2015 - Sydney; CEIV Pharma Workshop
Air Cargo Industry Concerns and Challenges Heavily regulated industry with no global standards and certification for handling of pharmaceutical products Regulations for transporting pharmaceutical products vary around the world Increasing number of regulations around the world to implement and comply with Increasing number of audits Airlines, GHAs and forwarders subjected to multiple audits for handling, transportation and distribution ( e.g. WHO Appendix 5, EU 92/25/EEC, IATA PCR Chapter 17 & TCR) No global certification for handling of pharmaceutical products 35 07 December 2015 - Sydney; CEIV Pharma Workshop
Shippers Expectations in Cold Chain Modal shift is a reality because shippers need products to maintain integrity and efficacy during transportation Compliance , standardization , accountability and transparency across the supply chain Properly trained stakeholders on regulations and standards Adequately equipped facilities throughout the supply chain Global certification for handling of pharmaceutical cargo Common audit format to minimize the disruptions and increase effectiveness Ability to easily search and identify stakeholders that meet requirements 36 07 December 2015 - Sydney; CEIV Pharma Workshop
37 07 December 2015 - Sydney; CEIV Pharma Workshop
Quotes from The Loadstar (Sep. 2013) “Air freight’s share of global pharmaceutical transport has plummeted from 17% in 2000 to just 11% today… on the basis of quality rather than price ” “ We need you, IATA , to spearhead the air cargo GDP standard development. It can only be you , and we are waiting for a long time already – way too long, and I don’t know why it is not happening . My question to IATA and the carriers behind IATA is – are you really willing? ” “You have various standards and systems out there and it is a nightmare for those that are inside the sandwich, the ground handler, who is forced to enforce various systems and procedures – and it is chaos…IATA is sleeping ” 38 07 December 2015 - Sydney; CEIV Pharma Workshop
39 07 December 2015 - Sydney; CEIV Pharma Workshop
IATA a standard setting organization Ronald Schaefer, Project Lead, CEIV Pharma, IATA 40 07 December 2015 - Sydney; CEIV Pharma Workshop
Industry Cooperation in Air Cargo The nature of the business requires strong industry cooperation Security Safety Tempera- (e.g. ture Dangero Sensitive us Products Goods) Live E-Cargo Animals Special Cargo (ULD, Mail) 41 07 December 2015 - Sydney; CEIV Pharma Workshop
Industry Cooperation in Air Cargo The Time and Temperature sensitive goods play an important role in air cargo With the healthcare market Security becoming a key engine of the Safety global economy , pharmaceutical (e.g. Temperature and biomedical industries are Dangero Sensitive us Products facing new challenges in adapting Goods) to globalization. Live Speed to market is therefore E-Cargo Animals essential and the healthcare Special Cargo industry is increasingly dependent (ULD, upon air cargo. Mail) 42 07 December 2015 - Sydney; CEIV Pharma Workshop
Industry Cooperation Why is air cargo so important? Temperature Sensitive Products Immunization prevents 2.5 million deaths every year Air cargo is critical in flying vaccines to their destination in A life protected time to be effective. 43 07 December 2015 - Sydney; CEIV Pharma Workshop
IATA a Standard Setting Organization Implementation and dissemination of standards driven by industry Step 2: Dissemination Step 1: Implementation Industry feedback driving improvements: Support Adoption Need for standardization, such as in the handling of pharmaceutical Prove Concept products in air cargo environment Need to enhance partnership and communication Develop Standards Need to ensure appropriate training in the supply chain The industry usually asks IATA to address their needs to ensure compliance and quality services 44 07 December 2015 - Sydney; CEIV Pharma Workshop
IATA a Standard Setting Organization Supply Chain Approach IATA has a long standing tradition in developing standards with industry Industry has always been concerned with the lack of compliance to these standards 45 07 December 2015 - Sydney; CEIV Pharma Workshop
IATA a Standard Setting Organization IATA uses different means to disseminate standards in the industry 46 07 December 2015 - Sydney; CEIV Pharma Workshop
Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Logistics Ronald Schaefer, Project Lead, CEIV Pharma, IATA 47 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma To ensure the integrity of the product throughout the supply chain OBJECTIVES Prevent sanitary issues caused Improve handling of by temperature excursions during pharmaceutical products and transportation. compliance with existing regulations + Ensure product standards. integrity Elevate level staff competency Create a global and consistent through efficient and robust certification that industry can rely training program. on. 48 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma targets Who does CEIV Pharma target? The supply chain Trucking Freight Distributors Companies Forwarders Ground Airlines Airports Handlers 49 07 December 2015 - Sydney; CEIV Pharma Workshop
Center of Excellence for Independent Validators Improve together to protect and grow our industry… The Need The solution … for more safety, security and Develop standards with regulators efficiency and industry stakeholders … to raise the bar to (re)gain confidence Train industry stakeholders on standards and regulation … to improve compliance to Assess operations against standard standards/regulations check list … for independent assessments vs. Train independent validators on self-assessments standards and regulations … to identify and recognize the best Certify and then register best players players on a publicly website … to harmonize and reduce the number Get States recognition to ensure of audits audits are valid for all 50 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard … by applying the newly developed CEIV Pharma standard that focuses on global coverage and universality… IATA GUIDELINES GOOD DISTRIBUTION LOCAL + REGIONAL PRACTICES GUIDELINES E.g. Singapore + + GDP & GDPMDS or FAGG in Belgium = = CEIV Pharma: encompasses various regulations and standards e.g. EU GDP. covers GDP requirements. aims at covering international standards and country-specific requirements. aims at reducing the number of audits or simplifying them. aims to align air cargo stakeholders needs. 51 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard …. which aims at global and consistent assessments specific to air transport Assessment GDP’s are: in some cases very region centric GDP Local not consistent and not transparent regulations not supported by shippers for air cargo industry focused on storage of pharma, not transportation TCR not aligning stakeholders in the supply chain ignoring transport in areas such as such as ground/tarmac transportation and aircraft (un)loading which are not covered by existing GDPs. CEIV Pharma focus is placed on unique handling and storage circumstances that apply to air cargo transport 52 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard CEIV Pharma aims to avoid one of the most “dangerous misunderstandings” of GDP certification 1 4 5 Gap filled by non- Transport companies accredited bodies who face strong pressure to issue commercial GDP “QP” Certificates from be listed in the certificates which are not independent consultants EudraGMDP Database of compliant as they are not are also not valid companies meeting EU issued by competent GDP compliance supervisory authority 2 3 SOLUTION? As per EU GDP However GDP Competent Guidelines, only Authorities do not competent typically carry out GDP supervisory inspections at transport authorities can carry companies (shipping out GDP inspections companies) or at airport hubs Source: GDP Group, 14/10/2015 53 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard Review, compare against best practice, offer recommendations for change, identify and mitigate risks, develop implementation plan Issues tackled Criteria applied Content of manuals and guidelines Quality management Procedures for Audits Personnel Procedures for describing packaging Training systems Documentation Acceptance checklist quality and operating agreements Infrastructure + equipment Packaging requirements Operations Documentation & labeling Complaints, returns and counterfeit Acceptance & control Supplier management Facilities and equipment Self-inspections Staff training requirements Transportation Training adequacy and currency Specific provisions for brokers 54 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard Snapshot of the IATA Standard Check List Table of Content Example of Questions 55 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma standard IMPORTANT Non-Conformance Ratings: MINOR non-conformance – minor or less serious non-conformance which is unlikely to pose a risk to product quality; MAJOR non-conformance – failure to satisfy a key or mandatory requirement and/or one which may pose a risk to product quality; CRITICAL non-conformance – a major non-conformance which poses a risk to users and must be corrected immediately. 56 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Overview Ensure a higher and more consistent level of pharma handling through validations and trainings with registered IVs and instructors NEW EXISTING 1 2 3 4 5 Training Validation Re- Standards and (Recurrent Assessment (Audit) & Validation Regulations Training) Award (Re-Audit)* Establish validation Develop training Develop pre- Manage deployment Manage database checklist with contents validation of validators of validated Develop Audit documentation, industry assessment toolkit locations and Advocate for Develop a standard assessment criteria processes and operators Manage re- globally accepted for instructors and validation operations standards and validators exam methodology and consistently validation schedule Train instructors, Manage quality of regulations assessment tool Establish industry validators and validations Follow-up steering group industry Award and recognize stakeholders Manage database operators and of certified locations as "CEIV instructors and Pharma certified" validators 57 07 December 2015 - Sydney; CEIV Pharma Workshop
Certification Approach and Methodology IATA will certify companies in several steps 1 2 3 Preparation Assessment Validation Assemble team On-site assessment by On-site visit by an 5 Independent validator Independent Validator to Prepare project logistics Certification ensure full compliance with Assessment versus Send data and information the IATA CEIV Pharma minimum IATA Temperature request checklist and also review the Controlled Audit Checklist progress made against Send interview request Comparison against best recommendations during the sheet for first visit practice assessment phase ~ 4 weeks before Establish findings and offer Drafting of report assessment recommendations for ~ 6-8 weeks after the change assessment Develop implementation plan and secure resources Draft gap analysis report 4 Additional Training required for certification Training 58 07 December 2015 - Sydney; CEIV Pharma Workshop
Assessment Focus is on preparing the organization for validation and creating awareness Assessment Raise awareness On Pharma handling requirements Assess client To identify potential gaps using the IATA CEIV Pharma checklists Of facilities, staff, equipment, processes, practices, and Conduct on-site observation systems Prepare client For the subsequent validation exercise Capture and convey ‘ lessons To assist client in achieving "CEIV Pharma Certified" status learned ’ and suggest ‘best practice Analyze observations Highlight findings and provide recommendations and produce report Collaborative work Helping creating an action plan and project plan 59 07 December 2015 - Sydney; CEIV Pharma Workshop
Validation Validate to ensure compliance and that gaps have been closed Validation During the validation the independent validator will go through the At the end of validation checklist one more time and also review the progress made against decision on whether all recommendations during the assessment phase requirements have been fulfilled. Review of progress on action plan Action Packages • Schedule x Actions • Personnel • Quantitative • Qualitative Implementations 60 07 December 2015 - Sydney; CEIV Pharma Workshop
Assessment and Validation Deliverables Step 1: Assessment Step 2: Validation Pharma handling criteria checklist. Progress report to review the progress made against recommendations during the Report covering the findings and assessment phase. recommendations based on the assessment. Implementation plan update . Implementation plan . Recommendation to award certification as Report and implementation plan will set out "CEIV Pharma certified" based on satisfactory assumptions, findings, results, conclusions and compliance of CEIV criteria. recommendations and will specifically: Presentation of the validation findings to Senior Identify critical elements that are not Management. compliant with national and international Regulations and the defined CEIV Pharma Handling criteria (e.g. TCR); Outline the impact of non-compliance ; and Identify elements that are inefficient . Presentation to Senior Management . 61 07 December 2015 - Sydney; CEIV Pharma Workshop
Training required for certification Successful completion of the courses is essential for certification Training required for certification Audit, Quality and Risk Temperature Controlled Management for Temperature Controlled Cargo Cargo Operations Successful completion of: 2 key personal on the “audit” training (5 days); 2 key personal distance learning “handling” training; and 2 competent personal on the “handling” training (3 days ). 62 07 December 2015 - Sydney; CEIV Pharma Workshop
Training Temperature Controlled Cargo Operations Training required for certification Key topics: The regulatory environment Overview of the global pharmaceutical industry The differences between “ordinary” perishables and healthcare products Packaging Technology Documentation and Labelling Handling Procedures and Acceptance Control Temperature Management in the supply chain The critical control points and associated risk factors Service Level Agreements (SLAs) and Standard Operational Procedures (SOPs) Quality Management 2 competent personnel per station should be trained on the Classroom course 2 key personnel per station should be trained on the Distance Learning course 63 07 December 2015 - Sydney; CEIV Pharma Workshop
Training Audit, Quality + Risk Mgt. for Temperature Controlled Cargo Training required for certification Key topics: The Regulatory framework Quality Management System (QMS) Audit and Quality Control Principles Self assessment and validation IATA Time and Temperature Sensitive Audit Checklist Effectiveness of risk management control Trigger corrective and preventive measures Quality Risk Management (QRM) Risk assessment, control and management methodology Root Cause Analysis and Lean Basics 2 key personnel per station should be trained on the Classroom course 64 07 December 2015 - Sydney; CEIV Pharma Workshop
Training Requirements Training required for certification Audit, Quality and Risk Temperature Controlled Who should be trained Management For Temperature Cargo Operations Controlled Cargo 2 key personnel involved in handling Distance Learning Classroom (5 days) pharmaceutical products activities 2 competent personnel involved in handling Classroom (3 days) N/A pharmaceutical products activities 65 07 December 2015 - Sydney; CEIV Pharma Workshop
Training In-Company vs Training Center TRAINING IN-COMPANY CENTER TRAINING Cost $ $$ No. of Participants 4 20 Location Inflexible Flexible Benefits of In-Company Training Receive quality training from IATA instructors and staff at the location of your choice Transfer skills quickly to your entire team Save on team travel and training costs 66 07 December 2015 - Sydney; CEIV Pharma Workshop
Training Two methods of delivery: Classroom and Distance Learning CLASSROOM DISTANCE LEARNING Training Center In-Company IATA Training at All classroom courses workplace. All in- are developed and Self-study: Manage learning to fit own company courses are delivered by IATA schedule. developed and Instructors or staff Study at own pace using a manual, e- members. delivered by IATA book or both At IATA Training Center Instructors Write exam at one of IATA's 60 Trainings can be (scheduled classes examination locations worldwide. Class room setting customized to fit your E-learning: Get the complete learning Exam at the end of company's training experience from your computer. Learn class needs from fun, interactive materials and write Class room setting your exam online. Exam at the end of class 67 07 December 2015 - Sydney; CEIV Pharma Workshop
Additional Training Introduction to Time and Temperature Pharmaceutical Products Additional Training 4-6 hours training. Key topics: Pharmaceutical products Processes & procedures related to job functions Identification and labelling Effect of temperature on pharmaceutical products Avoidance of counterfeits Passive and active packing Product security All personnel involved in handling pharmaceutical products activities per station should be trained on “IATA Introduction to Time and Temperature Pharmaceutical Products course“ ( or equivalent)) within period of 12 months after the “Certification” 68 07 December 2015 - Sydney; CEIV Pharma Workshop
Path to certification Assessment Step 1 Training Step 2 Validation Step 3 Certification!!! Training (remaining staff) Step 4 69 07 December 2015 - Sydney; CEIV Pharma Workshop
Certification Award Certificate "CEIV Pharma certified" Example 70 07 December 2015 - Sydney; CEIV Pharma Workshop
Certification Timeline (general approach) 8-12 Preparation Assessment 4 weeks Validation weeks 2 days on- 1-2 days on- site site Timeframe depends on results of assessment. Additional Training required for certification Training 8-12 weeks Ideally completed before 12 months after assessment. certification Needs to be completed before validation. 71 07 December 2015 - Sydney; CEIV Pharma Workshop
Recertification Recertification will take place every two years – includes assessment and one refresher training plus a validation if necessary "CEIV Pharma Certified" Re-assessment X 2 years 1 - 2 days Validation Close gaps 1 - 2 days One Refresher Training e.g. update on new regulations, development on new standards, development of new containers, etc. 72 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Certification Approach There are different approaches to obtain certification Individual Community Coalition One company A group of A group of decides to get companies at companies "CEIV Pharma one airport decide to get Certified“ decide to get "CEIV Pharma "CEIV Pharma Certified" at One or several Certified" several airports stations to form several Form a “pharma “pharma gateway” gateways” Supply chain Supply chain approach approach 73 07 December 2015 - Sydney; CEIV Pharma Workshop
Advocacy Strong emphasis on engaging stakeholder and advocate for endorsement and recognition WHO? TASK Industry Approve standards Time and Temperature Task Group – Approve trainings CEIV Pharma Steering Group Global WHO Global Shippers Forum (GSF) Cool Chain Association FIATA TIACA IQPC Endorse + recognize Regional standards US GDP EU Endorse + recognize Local trainings Local stakeholder associations (Shippers, Freight Forwarders, Ground Handlers, Airlines) Local BARs 74 07 December 2015 - Sydney; CEIV Pharma Workshop
Project structure - Who is involved and who can participate? Everyone in the value chain can participate in the certification process Example (BRU Cargo) Pharma shippers Forwarders with pharma focus Handlers Truckers Facilitators Airlines Regulators TTTF 75 07 December 2015 - Sydney; CEIV Pharma Workshop
Project structure The project is conducted in close cooperation with relevant stakeholders Example (BRU Cargo) 76 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma – Who is auditing? Qualification and management of independent validators (IV) Qualification Management IVs are registered in IATA IATA conducts preliminary interview with candidate to pre- database and available to complete the assessments and qualify candidate for training validations IVs must undergo IATA training Coordination of IVs is IVs need to complete trainings managed by the IATA team for within six months assessments and validations IV’s can also become IV cannot have been in a instructors but need to undergo commercial relationship with the IATA Train-the-trainer course entity to be validated 12 months (optional) prior to the engagement 77 07 December 2015 - Sydney; CEIV Pharma Workshop
IV Qualification + Recruitment Process Pharma Handling On-the-job Pre-qualification Interview Diploma Training assessment • Pharma • Motivation; • TCC • 1 on-site and/or • Social fit; Operations; assessment Auditing • Audit, Quality as a trainee. • Experience; background; + Risk • Expectations. • Cargo Management. experience; or • Ground handling experience. Independent Validator 78 07 December 2015 - Sydney; CEIV Pharma Workshop
Visibility for CEIV Pharma validated entities Validated entities will become visible on IATA’s website Search Results Details on a validation 79 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma: Status update of program Ronald Schaefer, Project Lead, CEIV Pharma, IATA 80 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Development From Pilot to Launch Launch of Community Joint development of Concept at BRU Community Concept with BRU SATS Pilot Official launch of CEIV Pharma program Discussion with SATS about a Pilot Development of CEIV Development of CEIV Development of CEIV Pharma Standard Pharma Standard 1.0 Pharma Standard 2.0 3.0 + Guidelines Unreliable cargo industry loosing pharma industry: IATA sleeping 03/15 05/15 09/13 11/13 01/14 03/14 05/14 07/14 09/14 11/14 01/15 81 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Checklist CEIV Pharma checklist and guidelines will be included in IATA’s Temperature Control Regulations as Annex CEIV Pharma Audit Checklist CEIV Pharma Audit Guidelines 82 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Certified Pharmaceutical Trade Lanes Development 1 2 11 11 2 1 1 1 2 1 1 1 1 1 3 6 9 1 1 1 1 1 Locations 18 Certification Completed 1 1 45 Certification in Progress 1 97 Certification in Discussion * 1 * Estimate 83 07 December 2015 - Sydney; CEIV Pharma Workshop
List of companies CEIV Pharma certified More companies will be added before the end of 2016 84 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma – Entities Certified European Community (Corporate) (Station) Locations 17 Certification Completed 28 Certification in Progress 85 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma European Community { 2 nd Group } Locations 17 Certification Completed 28 Certification in Progress 86 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Asian Community Locations 1 Certification Completed 7 Certification in Progress 87 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Middle East Community Locations 0 Certification Completed 1 Certification in Progress 88 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma Latin American Community Locations 0 Certification Completed 1 Certification in Progress 89 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma North American Community Locations 0 Certification Completed 1 Certification in Progress 90 07 December 2015 - Sydney; CEIV Pharma Workshop
CEIV Pharma African Community Locations 0 Certification Completed 1 Certification in Progress 91 07 December 2015 - Sydney; CEIV Pharma Workshop
Number of entities assessed IATA expects to have assessed 56 entities by end of 2015 …and counting Entities assessed / region in 2013 -2015; Entities assessed 2013 - 2015; in no. of entities assessed in no. of entities assessed Total (2013-2015) 1 1 2 2 1 15 56 60 42 Area 3 Area 2 Area 1 Area 4 Area 5 Area 1: The Americas Area 2: Europe / CIS 14 Area 3: Asia / Pacific 1 Area 4: MENA / Africa Area 5: North Asia Source: IATA 2013 2014 2015 92 07 December 2015 - Sydney; CEIV Pharma Workshop
Number of entities certified IATA expects to have a minimum of 30 entities certified by the end of the year… and counting Entities certified / region by 2015; Entities certified by 2015; in no. of entities assessed in no. of entities assessed Total 1 6 24 Minimum no. of entities that will finalize certification. Actual number will be 23 18 higher. Area 3 Area 2 Area 1: The Americas Area 2: Europe / CIS Area 3: Asia / Pacific 6 Area 4: MENA / Africa Area 5: North Asia 2014 2015 Source: IATA 93 07 December 2015 - Sydney; CEIV Pharma Workshop
Number of entities assessed IATA will have conducted assessments at 19 airports between SEP/2014 and DEC/2015, assessments at additional airports are already planned for Q1/2016 Entities assessed 2013 – 2015 by Airports; Entities assessed / region in 2015; in no. of entities assessed in no. of entities assessed Total 19 1 6 1 2 1 1 13 13 Area 3 Area 2 Area 1 Area 4 Area 5 5 Area 1: The Americas 1 Area 2: Europe / CIS Area 3: Asia / Pacific 2013 2014 2015 Area 4: MENA / Africa Source: IATA Area 5: North Asia 94 07 December 2015 - Sydney; CEIV Pharma Workshop
Advocacy Governance Support from Shippers Spain Belgium 95 07 December 2015 - Sydney; CEIV Pharma Workshop
Endorsement from European Shipping Council 96 07 December 2015 - Sydney; CEIV Pharma Workshop
Endorsement from Belgian Regulator On November 25, 2014, the Belgian Regulator FAGG – AFMPS formally endorsed the CEIV Pharma Program The Belgian regulator, the federal agency for medicines and health products (famhp) is endorsing the IATA CEIV program. It has been involved in the BRUcargo community certification from the start of the program. Famhp Inspectors have also participated in the training sessions and workshops. Josiane Van der Elst, Director General DG Inspection FAGG says “ Although this type of IATA certification is not an authority-issued regulatory document, initiatives of structured control on transport are important and welcomed by famhp DG INSPECTION. The IATA certification gives more confidence that pharmaceutical air freight shipments are handled in accordance with EU GDP guidelines”. fagg – afmps, November 25, 2014 97 07 December 2015 - Sydney; CEIV Pharma Workshop
Testimonials The program helps reducing the scope of shipper audits. CEIV is good sales tool to promote our business to clients: it ensures a robust cold chain in every step in the supply chain through the Holistic/community approach is the airport for handling the pharma competitive advantage vs other shipper’ temperature sensitive program. The fact that the products. program is industry specific is a key differentiator vs GDP. Eric Veeckmans, UTi Brussels, Freight Forwarder Frank van Gelder, Adelantex, Freight Forwarder This is not an IATA program. It was drawn up by the pharma shippers and ourselves and disseminated by IATA. The criteria are set by the shippers and ignoring this program is ignoring the interests of the pharmaceutical industry.” Steven Polmans, Head of Cargo, Brussels Airport 98 07 December 2015 - Sydney; CEIV Pharma Workshop
Transforming Challenges into Success The importance of partnerships
Questions and Answers Ronald Schaefer, Project Lead, CEIV Pharma 100 07 December 2015 - Sydney; CEIV Pharma Workshop
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