CEIV Pharma Webinar Thursday 14 May 2015

Transcription

1 CEIV Pharma Webinar Thursday 14 May 2015

2 Introduction Andrew Lyall Marketing & Business Development, Manager, Air Service Cargo Sales Halifax International Aviation Authority ACI NA Brandon Fried Executive Director Airforwarders Association

3 Introduction

4 IATA Moderators / Presenters Frederic LEGER Director, APCS Products LegerF@iata.org Ronald SCHAEFER Project Lead, CEIV Pharma SchaeferR@iata.org

5 Aim of the workshop Understand what are the risks and the potential gaps along the cool chain Hear what the industry expectations are Learn how IATA s standards improve the handling of pharmaceutical cargo Understand the practical solutions IATA proposed to the industry by means of certification Hear from the companies that are undergoing CEIV Pharma Certification Seek your input and constructive feedback on the solution IATA is implementing in the industry

6 Agenda 13:00 13:10 Welcome and introduction Andrew Lyall, ACI NA Brandon Fried, Airforwarders Association Pharmaceutical business - A growing segment? Frederic Leger, Director, APCS Products, IATA 13:10 13:20 13:20 13:40 13:40 13:50 13:50 13:59 13:59 14:00 Pharma Shippers Voice Brad Elrod, Director, Global Conveyance Security; Global Operations Compliance Management, Pfizer Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Logistics Ronald Schaefer, Project Lead, CEIV Pharma, IATA BRU Airport CEIV Community Approach Steven Polmans, Head of Cargo, Brussels Airport Company Questions and Answers Closing Remarks

7 Pharmaceutical business - A growing segment? Frederic Leger, Director, APCS Products, IATA

8 The global biopharma sales trend to go upwards A promising forecast Global Biopharma Sales Trend ($ Billions) $1, $1, $1, $ $ $ $ $- $ $ $ $1, $ $ $1, $ $ $1, $ $ Cold Chain (+61% growth) Total (+31% growth) Source: Pharmaceutical Commerce Non-Cold Chain (+24% growth) For cold-chain logistics, the top driver is the greater adoption of cold-chain products in developing markets. The continued but slowing development of new drugs also contributes to growth, mainly in developed markets. Slower global economic and population growth is a negative. The outlook is for continued expansion through 2018, at an average growth rate of about 6% per year, about the same as the 6% uptrend in the forecast last year.

9 Spending in biopharma logistics to rise to meet demand An encouraging outlook Global Biopharma Logistics Spending ($ Billions) $80.00 $70.00 $60.00 $50.00 $40.00 $30.00 $20.00 $10.00 $- $7.30 $8.40 $52.30 $55.30 $9.30 $59.50 $10.30 $ Non cold chain Cold chain Biopharma logistic growth is coming from 5 main drivers: More temperature sensitive products Greater demand and so volume High product value and so greater to lose Global manufacturers and worldwide distribution More regulatory interest Most of the growth in sales will be outside North America and Europe. Asia is expected to account for the largest regional share with more than $1 billion of cold-chain growth through 2018.

10 Cold chain logistics around $8.36 billion in 2014 An increase in opportunity Estimated Breakdown of Cold-Chain Logistics Costs in 2014 ($ Billions) It is estimated cold-chain logistics spending in 2014 will be about $8.4 billion worldwide in a $64 billion overall pharma logistics market. $6.80 $5.60 $48.60 Source: Pharmaceutical Commerce $2.80 Cold-chain transport Cold-chain packaging Non-cold-chain transport Non-cold-chain packaging $5.6 billion will be in transportation $2.8 billion will be in specialized tertiary packaging and instrumentation such as: insulated boxes; blankets; phase-change materials; active temperature-control shipping containers; and various temperature sensors and recorders.

11 Top 25 exporting countries accounted for 95% ($434B) Of the world s reported pharmaceutical exports in 2012 Top 25 exporting countries ($ Billions) Source: UN Comtrade statistics

12 25 importing countries - US is #1 by a wide margin Of the world s reported pharmaceutical imports in 2012 Top 25 importing countries ($ Billions) Source: UN Comtrade statistics

13 Country-country export flows The largest country-country export flows are among the major European producers, the US, Canada and Japan Country-country export flows ($ Billions) Source: UN Comtrade statistics

14 Pharma Shippers Voice Brad Elrod, Director, Global Conveyance Security; Global Operations Compliance Management Pfizer Global Supply Chain and Portfolio Management

15 Pharma Shippers Expectations Expertise- This is the reason we look for a relationship with you. Connections Your contacts and connections are not ones we can easily develop, but urgently need. Presence With us, in the region, with the carriers, across the industry. Visibility - Where is our product, what is it s condition? Communication Keep us informed of issues or changes. Honesty Trust is one of the most critical aspects in this business.

16 What is Critical to Pharma Shippers? Quality Standards Regulatory standards drive our business, we expect our partners to know and follow them without fail. Consistent Performance The same service and quality, all the time. Security Protection of our product and supply chains are important, be involved in that process. Options If you have another option that makes sense, let us evaluate it for potential use. Responsiveness React to incidents in a timely and deliberate manner. Flexibility Know how to react to changes in the process.

17 How to Improve Competencies, Compliance & Visibility. Highlight Problems Let us know when you know; do not try and fix or cover it up without our input. Deliver Solutions Bring forward solutions and options on how to improve a process. Creative Processes Let us know of new technologies or solutions; you are likely to hear of things in this arena faster than we will. Be proactive Anticipate and head off problems before they become disasters. Partner Be a true partner, not simply a hired hand.

18 Center of Excellence for Independent Validators (CEIV) in Pharmaceutical Logistics Ronald Schaefer, Project Lead, CEIV Pharma, IATA

19 IATA a Standard Setting Organization Implementation and Dissemination of Standards Step 1: Implementation Industry feedback driving improvements: Need for standardization in the handling of pharmaceutical products in air cargo environment Need to enhance partnership and communication Need to ensure appropriate training in the supply chain Step 2: Dissemination Support Adoption Prove Concept Develop Standards The industry usually asks IATA to address their needs to ensure compliance and quality services

20 IATA a Standard Setting Organization Supply Chain Approach to address Time and Temperature Sensitive Products IATA has a long standing tradition in developing standards with industry Industry has always been concerned with the lack of compliance to these standards

21 Industry Cooperation in Air Cargo The nature of the business requires strong industry cooperation Temperature Sensitive Products Security Safety (e.g. Dangero us Goods) Live Animals Special Cargo (ULD, Mail) E-Cargo

22 Industry Cooperation Why is air cargo so important? Temperature Sensitive Products Immunization prevents 2.5 million deaths every year A life protected Air cargo is critical in flying vaccines to their destination in time to be effective.

23 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; in % HOWEVER 12 Source: Pharmaceutical Commerce Over the past 10 years, air carriers, handlers and freight forwarders have responded with branded products and services to grab a share of this lucrative and niche market. Air cargo s share of global pharmaceutical products transport (in %)

24 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 Annual product losses between US$ billion due to various reasons including temperature excursions during transport and shipping. Due to a lack of compliance, standardization, accountability and transparency across the air transport supply chain The use of air-mode transportation is reconsidered unless industry partners ensure quality services

25 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

26 Air Cargo Supply Chain Challenges From origin to destination pharmaceutical products can be exposed to different climates Manufacturers & Shippers Packaging Loading Solutions Providers Origin-Destination Air Carrier In-Flight Conditions +35 C -10 C Handling Origin Forwarders & Trucking Co s. Road Transport Airport Ground Handlers Handling Airside Transport Airport Ground Handlers Destination Forwarders & Trucking Co s. Unloading Distributors & Consignees Road Transport +35 C -10 C

27 Critical Issues Raised by the Shippers Shippers have difficulties identifying industry stakeholders that meet standards and regulations at origin and destination Example of Flow from BRU to SYD Shipper Forwarder X BRU Forwarder Y SYD Consignee Pick-up In Out In Out In In Out BRU out SIN in out SYD in In Out Ground handler BRU Airline BRU SIN - SYD Ground handler SYD 14 milestones from start to end. Source: BRUCargo HOW CAN YOU MANAGE THIS?

28 Shippers Expectations in Cold Chain Shippers need service providers that maintain product 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

29 Center of Excellence for Independent Validators Improve together to protect and grow our industry The Need for more safety, security and efficiency The solution Develop standards with regulators and industry stakeholders to raise the bar to (re)gain confidence to improve compliance to standards/regulations Train industry stakeholders on standards and regulations Assess operations against standard check list for independent assessments vs. self-assessments Train independent validators on standards and regulations to identify and recognize the best players Certify and then register best players on a publicly website to harmonize and reduce the number of audits Get States recognition to ensure audits are valid for all

30 CEIV Pharma To ensure the integrity of the product throughout the supply chain OBJECTIVES Prevent sanitary issues caused by temperature excursions during transportation through harmonized standards. Improve handling of in compliance with existing regulations & standards. Elevate level staff competency through efficient and robust training program. Create a global and consistent certification that industry can rely on. Ensure product integrity maintained during transportation.

31 CEIV Pharma targets Who does CEIV Pharma target? Trucking Companies Freight Forwarders Distributors Ground Handlers Airlines Airports

32 Goal of CEIV Pharma Ensure a higher and more consistent level of pharma handling through validations and trainings with registered IVs and instructors EXISTING NEW Training Pre- Validation Standards and (Recurrent Validation (Audit) & Regulations Training) Assessment Award Re- Validation (Re-Audit)* Advocate for globally accepted standards and regulations Establish validation checklist with industry Establish industry steering group Develop training contents Develop assessment criteria for instructors and validators exam Train instructors, validators and industry stakeholders Manage database of certified instructors and validators Develop prevalidation assessment toolkit Develop a standard validation methodology and assessment tool Manage deployment of validators Audit documentation, processes and operations consistently Manage quality of validations Follow-up Award and recognize operators and locations as "CEIV Pharma certified" Manage database of validated locations and operators Manage revalidation schedule

33 Certification Approach and Methodology IATA will certify companies in several steps 1 Preparation 2 Assessment 3 Validation Assemble team Prepare project logistics Send data and information request; Send interview request sheet for first visit 2 weeks before assessment On-site assessment by Independent validator Assessment versus minimum IATA Temperature Controlled Audit Checklist Comparison against best practice Establish findings and offer recommendations for change On-site visit by an Independent Validator to review progress made against recommendations during the assessment phase Drafting of report Min 6-8 weeks after the assessment 5 Certification Develop implementation plan and secure resources 4 Drafting of report Training required for certification Additional Training

34 Assessment Focus is on global coverage and universality Assessment IATA guidelines Good distribution practices Local and regional guidelines E.g. Singapore GDP & GDPMDS or FAGG in Belgium CEIV Pharma encompasses various regulations and standards e.g. EU GDP. includes in the check list the GDP requirements. aims at covering international standards and country-specific requirements. aims at reducing the number of audits or simplifying them.

35 Training required for certification Successful completion of the courses is essential for certification Training required for certification Temperature Controlled Cargo Operations Risk, Audit and Quality of Temperature Controlled Cargo 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).

36 Path to certification Step 1 Assessment Step 2 Training Step 3 Validation Certification!!! Step 4 Training (remaining staff)

37 Certification Award Certificate "CEIV Pharma certified" Example

38 Certification Timeline (general approach) Preparation 2 weeks Assessment 2-8 weeks Validation 2-4 days onsite Timeframe depends on results of assessment. 2-4 days onsite Certification Training: IATA Pharmaceutical Handling Diploma 2-8 weeks Ideally completed before assessment. Needs to be completed before validation. Additional Training 12 months after certification

39 Recertification Recertification will take place every two years includes assessment and one refresher training plus a validation if necessary "CEIV Pharma Certified" Re-assessment 2 years 1-2 days X Close gaps Validation 1-2 days One Refresher Training e.g. update on new regulations, development on new standards, development of new containers, etc.

40 CEIV Pharma Certification Approach There are different approaches to obtain certification Individual approach: One company decides to get "CEIV Pharma Certified" Community approach: A group of companies at an airport decide to get "CEIV Pharma Certified" to form a pharma gateway Coalition approach: A group of companies decide to get "CEIV Pharma Certified" at several airports to form several pharma gateways

41 Advocacy governance Strong emphasis on engaging stakeholder and advocate for endorsement and recognition Industry WHO? Time and Temperature Task Group CEIV Pharma Steering Group TASK Approve standards Approve trainings Global Regional Local WHO FIACA TIACA US Airfreight Association EU Global Shippers Forum (GSF) Cool Chain Association ACI Local stakeholder associations (Shippers, Freight Forwarders, Ground Handlers, Airlines) Local BARs Endorse + recognize standards Endorse + recognize trainings

42 CEIV Pharma Who is auditing? Qualification and management of independent validators (IV) Qualification IATA conducts preliminary interview with candidate to prequalify candidate for training IVs must undergo IATA training IV s can also become instructors but need to undergo the IATA Train-thetrainer course (optional) Management IVs are registered in IATA database and available to complete the assessments and validations Coordination of IVs is managed by the IATA team for assessments and validations IV cannot have been in a commercial relationship with entity to be validated 12 months prior to the engagement

43 Visibility for CEIV Pharma validated entities Validated entities will become visible on IATA s website Search Results Details on a validation

44 CEIV Pharma: Status update of program

45 CEIV Pharma Certified Pharmaceutical Trade Lanes Development Locations Certification Completed Certification in Progress 9 Certification in Discussion

46 Advocacy Governance Support from Shippers Spain Belgium

47 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

48 Transforming Challenges into Success The importance of partnerships

49 BRU Airport CEIV Community Approach Steven Polmans Head of Cargo, Brussels Airport Company

50 Brussels Airport Innovating the cool chain Steven Polmans Head of Cargo Brussels Airport Company Munich, May 5th 2015

51 Agenda BRU Airport CEIV Community Approach: - Why this certification is important / How does it fit with the BRU Pharmaceutical Project? - Why a community approach? - Scope of the CEIV Pharmaceutical project in BRU / Planning of the program - Benefits for entities involved, BRU airport and Belgium

52 Pharma Context Indexed growth in pharmaceutical air exports Growth in air weight indexed to 100 Belgium Germany Switzerland Source: the European Cluster Observatory France Italy UK

53 Pharma Context Strategic priority develop our USP as: preferred European pharma gateway Customer intimacy: problems of the pharma shippers are our problems Continuous relation with the pharma shippers in Belgium Several pharma related studies together with industry and government bodies Partnerships with the industry: IATA TTTF, CCA, local shipper forum, IATA pharma training BRU

54 Pharma Context Why air cargo for pharmaceutical shipments? No (better) alternative available for that shipment or route at that time What are your main concerns when using air? Integrity of the cool chain, no transparency, lack of knowledge, inconsistency, blaming others, what happens at the airport??

55 Pharma shippers have clear expectations Lane Selection -Priority = direct connection -Capacity & frequency Integrated cold chain: -Reliable -Transparant -Pharma mindset ROUTE Quality LANE choice COST Source: Brussels Airport benchmark study, by Flemish Institute for Logistics

56 Airfreight industry faces many challenges Temperature Excursions Where do they occur? Low Risk Medium Risk High Risk

57 Agenda BRU Airport CEIV Community Approach: - Why this certification is important / How does it fit with the BRU Pharmaceutical Project? - Why a community approach? - Scope of the CEIV Pharmaceutical project in BRU / Planning of the program - Benefits for entities involved, BRU airport and Belgium

58 BRUcargo Pharma Certification Program Aim: Create a BRUcargo pharma label offering shippers a high quality, consistent and transparent service at our airport PHARMA@BRUcargo

59 BRUcargo Pharma Certification Program Why not GDP but create something different??? - GDP is storage of pharma, not transportation - Not specific to the air cargo industry, not for all participants in the logistical chain - Lack of consistency and transparency

60 BRUcargo Pharma Certification Program Benefits of a community approach: - Lower cost: less travel, joint trainings, group purchase - Focus on the chain and the total community: all stakeholders - Bigger visibility towards outside market - Critical mass from the beginning - Networking opportunity and effect / learning from each other

61 Agenda BRU Airport CEIV Community Approach: - Why this certification is important / How does it fit with the BRU Pharmaceutical Project? - Why a community approach? - Scope of the CEIV Pharmaceutical project in BRU / Planning of the program - Benefits for entities involved, BRU airport and Belgium

62 BRUcargo Pharma Certification Program Focus : Quality Focus Integrated on quality cold chain Reliable Transparent Pharma mindset Objective Improve handling of pharmaceutical cargo: reliable/transparent/temp-controlled Action points Standardize and align the pharma handling process Involve the entire cool chain at the airport Airlines Ground Handling Agents Forwarders Truckers Shippers

63 Secure cold chain transportation Complex process PROJECT SCOPE +35 C -10 C Community

64 Brussels Airport role (1) Moderating the program Q : Start project pharma certification strategy: inform and involve all stakeholders, scope, targets, Q : Develop audit framework and checklist for all participants in the air cargo chain Q : Validation by the major pharma shippers Operational testing and evaluation of audit methodology

65 Brussels Airport role (2) Moderating the program Q : Identifying potential participants for community certification Alignment with IATA: CEIV Pharma Program TTTF Q : Kick-off audit BRUcargo locations and partners 1st group: 2nd group:

66 Brussels Airport role (3) Moderating the program Q : Training: IATA BRU training school Brussels Airport offers local pharma trainings Q & Q : First certification of compagnies

67 Support Regulators and customer involved from the start Pharma shippers: -Formal support letters -Participation in workshops and training

68 Support Regulators and customer involved from the start Regulator: -participation in workshops and training -Formal statement

69 Participants in the cold chain process Involve the entire cool chain at the airport Truckers Forwarders (with dedicated pharma services) Handlers Airlines

70 Project Structure: -Clear governance structure -Strong project management

71 Agenda BRU Airport CEIV Community Approach: - Why this certification is important / How does it fit with the BRU Pharmaceutical Project? - Why a community approach? - Scope of the CEIV Pharmaceutical project in BRU / Planning of the program - Benefits for entities involved, BRU airport and Belgium

72 Outcome of the program Participants feedback All participants: are positive about the added value of the program would participate again recommend CEIV pharma The fact that the program is industry specific is a key differentiator CEIV is a good sales tool to promote our business to clients The Brussels Airport community approach brings many benefits The program focusses on process as well as on operation Reduced temperature risk profile for the cool chain through the airport, resulting in simplified audits (pharma shippers feedback)

73 Next steps Launch of a second group at Brussels Airport Next steps : Launch of a second group in 2015

74 Brussels Airport? Questions? Gateway for the time and temperature controlled supply chain

75 Questions and Answers

76 Closing Remarks

77 CEIV Pharma Key Benefits The CEIV Pharma is a win-win situation for the industry Shippers Conduct simpler audits of operators Obtain guarantee that products would be handled in line with regulations Experience lower rate of damage and loss due to temperature excursions Be able to prepare their products ready for acceptance Regulators Assured of safety of pharmaceutical products shipped by air Access structured and consistent training and registry of independent validators and assessed operators Airlines, GHAs, Forwarders, Airports Protect and grow revenues in fastest growing segment of air cargo Obtain recognition for operations, facilities and staff after meeting standards Experience simpler audits from various organizations Promote their best practices to the shipper s community IATA Disseminated standards in the industry Common audit criteria and global certification Promote air transport and so limit the modal shift

78 THANK YOU For further information, contact: Ronald SCHAEFER Project Lead, CEIV Pharma Miami, FL Tel: Mob: