Amy Shortman spoke with Emma Green from World Pharmaceutical Frontiers about emerging technologies and the challenges with our industry. Read more here
Category: Uncategorized
ASC to present at 2019 HDA PCSC Educational Seminar, Novartis, N.J, USA.
ASC will be presenting on 9th May at 09:00 on the subject of ‘Demystifying Good Distribution Practice (GDP) Compliance’
‘For the past 10 years, Good Distribution Practice (GDP) has become something of a buzzword when discussing best practice within the pharmaceutical logistics industry. However, there remains a vast amount of confusion over what this means, especially when it comes to which guidelines and licenses apply to each part of the supply chain. Through case studies, learn more about GDP and its value in the logistics industry.’
The HDA Pharmaceutical Cargo Security Coalition (PCSC) Educational Seminar brings together those within healthcare, as well as many other industries, that ship and store sensitive, high-risk/high-value products — anywhere in the world. Held annually since 2006, this supply chain security educational event provides interactive instruction, with both indoor and outdoor activities, as well as case-study discussions. Attendees are introduced to government law enforcement and regulatory personnel (and vice-versa) to enhance knowledge of supply chain security best practices.
Seminar topics include:
- The technology surrounding shipment monitoring/tracking;
- The sharing of supply chain intelligence;
- Cyber supply chain security; and,
- Familiarization with like or similar industry supporting associations.
May 8 to 9, 2019 | Novartis Corporate Headquarters, East Hanover, N.J.
For further details and registration please click here.
PHARMA SECURITY WORLD 2019 ”ANTI-COUNTERFEITING, DRUG SERIALIZATION AND SUPPLY-CHAIN CONFERENCE”
On 19th/ 20th March 2019 in London, UK Corvus Global Events hosted the 2nd Annual Pharma Security World 2019 – Anti-Counterfeiting, Drug Serialization and Supply-Chain Conference, where Pharma industry experts shared various challenges faced, new strategies, case studies and use of innovative ideas and the conference will also offer opportunities to encourage partnerships and collaborations. ASC’s Tom Cochrane shared his 35+ years’ of experience on Supply Chain Security, the important of training those within the supply chain and focused in on the EU’s Falsified Medicine Directive andDrug Supply Chain Security Act (DSCSA)
‘The US is driving the path with the approved in 2013. DSCSA guide for end-to-end traceability is extended over a period of 10 years, with expectations sketched throughout the supply chain. The complete supply chain is relied upon to be electronically incorporated and all hubs of traceability to be built up by November 2023. The E.U.’s Falsified Medicines Directive requires drug companies to adopt mass serialization and other anti-counterfeiting measures starting in 2019. Manufacturers who operate in the E.U. will have to add unique identification numbers to the outer packaging of all prescription drugs, and equip containers with tamperproof seals. To guide customers from illicit online drug stores that supply fake medications, the FMD requires approved legitimate Internet drug stores to show a logo distinguishing them as E.U. approved drug retailers.’
The Conference deliberations were on the following themes:
• Understanding and meeting the needs of DSCSA, EU FMD and other global regulations
• Synchrony of the Pharma Industry and professional bodies against counterfeiting
• Tackling pharmaceutical crime – initiatives at multinational, EU and national level
• IP and regulatory enforcement
• Strategies for public awareness and patient protection
• Best practices to protect your brand
• The role of the Internet in aiding the counterfeiters – How to overcome the situation?
• Common Logo initiative in the EU for online pharmacies
• Brand Protection & Securing supply chain integrity
• End to End supply chain visibility
• Developing a sustainable Serialization strategy
• Global enterprise level solutions for anti-counterfeiting
• Integration of track & trace solutions in production and supply chain
• Smart Packaging, Labeling, Artwork, Warehouse & Logistics
• Effective Authentication Technologies
• Best selection of tamper-evident features
• Developing a RMP for your supply chain to protect your Brand, Product and Patient Safety
• Measuring the Effectiveness of a Good Quality System through frequent external and internal audits
• Debating the use and implementation of serialization, barcoding, and RFID
• Serialization Data and Analytics driven approach to increase supply chain agility
• Cloud-based technology complement big data solutions in monitoring and improving supply chain processes
• The need to understand and adopt new technologies like IoT, Analytics, Block chain, Machine Learning and Artificial Intelligence
• Case study: How companies are structuring their counterfeiting efforts and departments?
The Logistics Podcast
We love to chat and were delighted to speak with Kirsty Adams from SDH Logistics for their latest Podcast.
Check out The Logistics Podcast discussing ‘Pills in the post’ with Amy Shortman FCILT and Henry Moran. There is also an interview with the head of logistics at the House of Commons Wesley Auvache.
IQPC INSIGHTS: SUPPLY CHAIN EFFICIENCY AND NEW TECHNOLOGIES
The future of the pharma logistics sector will be characterised by solutions that are software driven rather than hardware driven. In this article, with insights from Amy Shortman, Founder and CEO of ASC Associates Ltd we will explore how the latest technologies will affect the sector, including:
• How new technologies will bridge communication between all parties and stakeholders in the supply chain
• What real time and predictive software systems mean for temperature excursion management
• How IoT and blockchain will shape a touchless, wireless, and secure logistics operation offering an ‘immutable level of traceability’ for products
Please click here for the full report
ASC will be presenting this year at TCL 2018, we look forward to seeing you there.
Supply Chain Efficiencies & New Technologies
January28th-31st2019
London,UnitedKingdom
Supply
ChainEfficiency
And
NewTechnologies
ExpertinsightfromAmyShortman
FounderandCEOofASCAssociatesLtd
Supply
ChainEfficiency
AndNew
Technology
AmyShortmanFounderandCEOofASCAssociatesLtd
RetroactiveLogistics:AThingofthePast…
IoTandblockchainwillenable
proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.
Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather
thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.
Adevice-agnosticsoftwaresystemthat
canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand
adapttonewertechnologiesfareasierthanever
before.
1
Pharma4.0,InternetofThings
Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?
“Clientscannowseewheretheirproductisinreal
time.”
Whatdoesinnovationlooklike?
Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time
intervention.
“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.
“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent
incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.
“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.
Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.
Betterstakeholdercollaboration
“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”
Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe
shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.
“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”
2
January28th-31st2019
London,UnitedKingdom
Supply
ChainEfficiency
And
NewTechnologies
ExpertinsightfromAmyShortman
FounderandCEOofASCAssociatesLtd
Supply
ChainEfficiency
AndNew
Technology
AmyShortmanFounderandCEOofASCAssociatesLtd
RetroactiveLogistics:AThingofthePast…
IoTandblockchainwillenable
proactiveshipmentmanagement.Nolongerwillpractitionersberestrictedtopost-shipmentforanalysisandexcursionmanagement,increasingthesector’sabilitytomitigaterisktotheproductandthepatient.
Thefutureofthesectorwillbecharacterisedbysolutionsthataresoftwaredrivenrather
thanhardwaredriven.Thebenefitofthisisthatlogisticsservicesandshipperswillnolongerbetieddowntoasingledevice,orgroupofdevicesthathaverestrictedconnectivity.
Adevice-agnosticsoftwaresystemthat
canswitchtothelatesttechnology,whichwillputtheshipperinamuchmoreflexiblepositionintermsoftheirpurchasingability.Itwillalsoensurethatthesectorcanmaintainfluidityand
adapttonewertechnologiesfareasierthanever
before.
1
Pharma4.0,InternetofThings
Formanyyears,thetemperaturecontrolledlogisticssectorsufferedfromtechnologystagnation.Isthisstillthecase?
“Clientscannowseewheretheirproductisinreal
time.”
Whatdoesinnovationlooklike?
Justonthehorizonisawidearrayofsoftwaresolutionsthatwillmarkashiftfromretrospectiveinterventiontoreal-time
intervention.
“Thebenefitofthesenewtechnologiesisthatit’sgoingtobereal-timeandpredictive.Whenexcursionsoccur,oraprocessdoesn’toccurasitshould,youhavetheopportunitytofixtheissueinreal-time,asopposedtoretrospectiveanalysis,”saysShortman.
“Abigpartofthesenewsolutionsishowthedataspeakstoallinvolvedparties.”Thedatacanbepulledfromdevicesandsenttoindividualsandorganisationswithinthesupplychaintoprevent
incidents.Thiscanbeanythingfromdamagereports,totheft,andtemperatureexcursions.
“Thesectorisnowatthestagewherewe’rebeginningtomoveawayfromhardwaresolutionsintosoftwaresolutions,”saysShortman.
Indeed,thelogisticssectordoesrunarisktopatientsifsoftwareissluggishinadaptingtomeettheindustry’schanges.However,Shortmanhighlightsthatinnovationisaroundthecorner.Therearenowproductscomprisedofindependentsoftwarethatcanconnecttoanydevicetype-andthiskindoftechnologyisavailableacrossthefullrangeoftransportsolutions.
Betterstakeholdercollaboration
“Thesectorhascomealongway,”Shortmansays.Whileitstillisn’tperfect,implementinganewtypeofsoftwaretransportationmanagementsystemissignificantlyfasterandmoreefficientthanitwasadecadeago.”Whatisavailableonthemarketnowisalmostlikeplugandplay,withAPIlinkstobringinrelevantdata,thistechnologyishugelybeneficialfromapush-pullpointofview.We’reseeingthatthesesolutionscanbesetupincrediblyquickly,andonceit’supandrunning,it’sallaboutensuringthattheworkflowscorrectly.”
Indeed,newtechnologieswillbridgecommunicationbetweenallpartiesandstakeholders.InaTCLscenario,apharmaceuticalcompanycansendatextmessagetoadriver,thedrivercandownloadanapp,andthentakephotographsofthesealofatemperaturereadoutwhilecollectingthe
shipment.Thisinformationcanbeuploadedinrealtimeandcanbesharedwitheveryoneonthesystem,accordingtoShortman.
“Ifanairlinewasusingsimilartechnologywecangivethematabletortheycanhaveatabletdevicewheretheycanalsouploadanyrelevantchecklists,againinrealtime,sothatwe’recapturingthataudittrailofwhat’shappening,whenit’shappening,whoit’shappeningby.”
2
ASC to speak at Chartered Institute of Logistics and Transport Conference 2019
ASC’s Amy Shortman will be sharing insights of how the logistics industry is adapting to Artificial Intelligence and her thoughts on the future.
The theme of this year’s conference will be “Artificial Intelligence in Supply Chain” held at Queen Anne Court, University of Greenwich, London, UK on Wednesday 20th February 2019. Save the date for now and more information on the programme will be communicated soon. To register click here
CILT have a wide-ranging panel of experts on the topic of AI with the aim to create networking opportunities with transport and logistics professionals for students, with discussions enabled during the event and at the various interactive breaks.
ASC support partners Virgin Atlantic Cargo in successfully obtaining WDA licence from the MHRA
ASC have been working with Virgin Atlantic Cargo for many years on a variety of different projects. The latest of these projects focused on assisting Virgin Atlantic Cargo to gain their WDA license for the London operations, which would enable them to offer their customers a GDP compliant service. Our work with Virgin Atlantic Cargo began in June 2016, and we are pleased to announce that they gained their WDA license in April 2018.
The support of senior management is critical for the successful outcome of any project, but particularly one that involves quality. ASC were privileged to work with a strong project team, led by Virgin’s Darren Sherlock, and we offer our congratulations to them.
“ASC have been instrumental in our growth into the healthcare market, which was recently punctuated with us achieving our WDA certification in the UK. From the initial gap analysis, developing SOPs, and input developing our quality management system, right through to the delivery of training and getting us ready for our final audit; their knowledge and expertise has ensured that we’ve executed each phase of the project successfully. We plan to continue to work with ASC as we further develop, and I’ve every confidence that with their guidance, Virgin Cargo will go from strength to strength in this area.”
Darren Sherlock – Manager, Products and Partnerships | Virgin Atlantic Cargo
THE BEGINNING OF A NEW JOURNEY – VIRGIN ATLANTIC CARGO SET THEIR SIGHTS ON COMPLIANCE
Gaining a WDA license requires extensive auditing and compliance, which is where ASC were able to offer advice and support. The first stage involved conducting the ‘ASC GDP Health Check’ on Virgin’s cargo operation and that of their Ground Handling Agents at London Heathrow, the Virgin Atlantic Cargo Hub, and Manchester. This was a thorough audit against EU Good Distribution Practice (GDP) Guidelines and Supply Chain Security. Virgin then took the findings and conducted a CAPA plan to close the non-compliances.
We supported Virgin throughout this process using regular project meetings to ensure momentum was maintained. As part of the project, ASC has trained 80 key personnel on our bespoke certified (GDP) training course, which is designed for logisticians by logisticians. Whilst many other GDP courses focus on wholesale activities, we have developed a course that demonstrates how GDP is applicable in pharmaceutical logistics.
Changing an airline environment into a facility that is operating to the same standards as a Wholesaler of Medicinal Products is a challenge. But Virgin Atlantic Cargo were dedicated to achieving these high standards, enabling them to demonstrate their on-going continuous improvements in quality. By mid-April 2018 the Virgin operation was audited by the MHRA and after a successful audit they received their WDA
WHY CERTIFICATION?
Virgin Atlantic are a global airline who were recently voted the 5th best airline in the world. Virgin Atlantic Cargo is the subsidiary responsible for the cargo and freight operation of the airline. Founded in 1984, it has been providing award winning services to their customers ever since.
Virgin Atlantic Cargo support the Life Science and pharmaceutical industry by offering a range of solutions for time and temperature sensitive products. Internationally accepted GDP guidelines play a key role in assuring transport and distribution of medicinal products for human use does not adversely impact product quality and integrity. The GDP guidelines focus on well-established pharmaceutical working procedures, and continuously improving distribution and handling expertise.
In the UK the MHRA requires companies hold a wholesale dealer license – or wholesale distribution authorisation (WDA) – when providing short-term storage for refrigerated items. In August 2014, the Medicine and Healthcare Products Regulatory Agency (MHRA) published the document Short- Term Storage of Ambient and Refrigerated Medicinal Product – Requirements for a WDA, which stated the following:
- Sites holding ambient products in excess of 36 hours must be licensed
- Sites where refrigerated products are held, even when this is for less than 36 hours, must be licensed (2)
Having these management systems in place gives the customers the confidence that the company have the controls in place to provide continuity, good quality and service.
THE BENEFITS OF A WDA
The WDA is a recognized global quality standard and plays a critical role in assuring transport and distribution of medicinal products for human use does not adversely impact product quality and integrity.
The license provides proof that the Virgin Atlantic operations are “fit for purpose” at their own and at their partners’ facilities. It also provides evidence that they are operating within a GDP compliant network.
Their customers can be assured that their shipments will be handled in a fully compliant manner.
PLANNING FOR THE FUTURE
The journey has only just begun for Virgin Atlantic Cargo. Regulations are updated, technology advances, and needs evolve, so remaining compliant will require Virgin Atlantic Cargo to remain up-to-date with the latest regulations. ASC will continue to provide advice and support to help Virgin Atlantic Cargo be the best and remain compliant moving forward.
ABOUT ASC AND OUR SERVICES
ASC is distinctive. In the pharmaceutical and healthcare worlds – where external threats to business and intellectual property are ever-increasing, we go above and beyond – dedicated to improving all aspects of supply chain logistics. Established in 2011 we have supported all the major stakeholders within the supply chain on GDP and Supply Chain Security.
With a relentless focus on innovation, security, safety, compliance and efficacy, we take extraordinary care with attention to detail. We advise. We assess. We train. We plan. We audit. We scope. We inspect. We implement. In person.
We’re there at the beginning of your journey, ever-present throughout, and with you at the end. And all along, we’re an experienced and knowledgeable partner, supporting your business to enable you to deliver on your own promises.
If you would like to have a chat about your requirements give us a shout. We’d love to hear from you.
ASC speaking at 8th Annual Conference Temperature Controlled Logistics in Frankfurt
ASC’s Tom Cochrane to Chair Day 1 and is giving the Keynote speech.
Tom will be sharing his 37 years of experience within the industry by giving the Keynote speech on ‘An Approach to Global Supply Chain Security in Today’s Pharma Industry’. Tom will cover the following topics:
- Identifying the risks in the supply chain
- Designing and implementing a security management system
- reviewing some examples
- Sharing best practice
This event will be held at The Steinburger, Frankfurt am Main, Germany on the 17th & 18th May 2018.
Some other topics covered within this conference will be:
- Explore applications of block chain, temperature monitoring and more. Embrace the globalization of distribution efficiently and safely
- Building a safe and effective global distribution network
- Shipping rout verification and cost optimisation
- Value of smart packaging
- Digitization of supply chain
We look forward to participating in this event organised by Fleming, and hearing updates from the industry by an esteemed list of speakers.
The first PCSC annual conference under the HDA
2018 HDA PCSC Educational Seminar
May 15 to 17, 2018 | Novartis Corporate Headquarters, East Hanover, N.J.USA
Last year I attended this event and was incredibly impressed. Having been to many conferences over the years I feel its rare nowadays to attend an event and leave feeling that you have been educated. The topics selected feel fresh and with a wide and diverse range of speakers, its lends itself to feel like a succession of brilliant college lectures. This is time well spent and if you were to attend one event this year, this should be it.
In 2017, PCSC became a service offering of the Healthcare Distribution Alliance (HDA), the national organization representing primary pharmaceutical distributors. HDA members are the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide.
Please find some further information below on this years event and I hope to see you there:
The HDA Pharmaceutical Cargo Security Coalition (PCSC) Educational Seminar brings together those within healthcare, as well as many other industries, that ship and store sensitive, high-risk/high-value products — anywhere in the world. Held annually since 2006, this supply chain security educational event provides interactive instruction, with both indoor and outdoor activities, as well as case-study discussions and “table-top” simulation exercises. Attendees are introduced to government law enforcement and regulatory personnel (and vice-versa) to enhance knowledge of supply chain security best practices.
Seminar topics will include:
- The technology surrounding shipment monitoring/tracking;
- The sharing of supply chain security intelligence;
- A table-top simulated cargo theft exercise;
- Cyber supply chain security; and,
- Familiarization with like or similar industry supporting associations.
Target Audience
This seminar is designed for industry professionals (within or outside healthcare) that ship and store sensitive, high-risk/high-value products — anywhere in the world. Also encouraged to attend are those that support shipping and warehousing operations, such as ground/air/sea/rail transportation entities; third-party logistics providers; freight-forwarders; customs brokers; insurers; and federal, state and local law enforcement; and regulatory agencies.
HDA’s PCSC welcomes Henry Moran as Advisory Board Member
We are delighted to announce that Henry Moran, our COO has been invited to join the prestigious HDA PCSC’s Advisory Board.
The Pharmaceutical Cargo Security Coalition (PCSC) offers supply chain security intelligence; access to contacts from industry, government and vendor trade disciplines; physical and supply chain security assessments; a reference library of supply chain security publications, articles and related documents; as well as opportunities to attend educational events. Primarily (but not exclusively) focused on the pharmaceutical industry, PCSC provides useful insights for anyone interested in supply chain security.
In 2017, PCSC became a service offering of the Healthcare Distribution Alliance (HDA), the national organization representing primary pharmaceutical distributors. HDA members are the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Learn more about HDA at www.hda.org.