Cold Chain & Temperature Control Distribution Online Summit

Understanding the Changing Regulatory Landscape, Exploring Regional Opportunities and Risks and Improving Collaboration to Drive Efficiency in your Supply Chain

Meet your Speakers

Click on a photo to view their bio
 
  • Riekert Bruinink
  • Martha Kliss
  • Lindsay Botham
  • Rajesh Pednekar
  • Humberto Laserna
  • Elena Adusei
  • Lisa Mazzoni
  • Claude Ammann
  • Andrea Graf-Gruber
  • Dr Mary Foster
  • Jean-Pierre Ph.D. Emond
  • Paul Glossop
  • Daniel Liebermann

69% say reducing or preventing product deviations and excursions is their top priority for 2012…do you agree?

As you probably know, over the past ten years, IQPC has launched in excess of ten cold chain events covering regions from Latin America and the US to Europe and South Africa, developing some 25,000+ cold chain contacts globally. It is as a result of feedback from this community that we bring you the second in the online series, continuing our truly global offering.

The event brings you top rated speakers from our global series of Cold Chain events in 10 different countries. A collection of expert advisors with the greatest content, latest thinking – the online programme offers the latest and greatest in all things temperature control.

 

As the 'Best of the Best', this platform offers an unparalleled insight into the most effective temperature control logistics, security and quality strategies.

 

Covering global regulatory, risk mitigation and logistical challenges, the online event will provide a forum for you to learn and explore new strategies from the comfort of your desk. In addition, we have designed the online platform to ensure you don’t miss out on networking -  as a participant, you can see who is 'logged in' and initiate a private chat to exchange ideas and contact details, as well as getting involved in Q&A.



Supply chains are becoming truly global, resulting in an increase in complexity and an increase in the pressure to deliver medicines safely to patients. Emerging markets also bring new regulatory and customs requirements as well as concerns for supply chain security, so the community is now assessing how to adhere to GDP and individual country requirements while maintaining a secure and effective chain of custody.


So what is your strategy to ensure effective logistics and safely deliver temperature sensitive, high value products?


 

We look forward to discussing this with you and your team online!

Kind regards,

 

Nicola Ambler 


P.s.

Do you find it’s always better to learn as a team? Take advantage of our group discounts below.





Highlights



Not just another cold chain event!

This is the only online cold chain event.  If we think about it… who uses a phone book, or a dictionary or encyclopaedia today?

The same rings true for cold chain, there is no 1 paper manual on cold chain requirements instead there are many regulatory guidance and industry standard documents that need to be understood and adhered to.

Most people today use the internet to find what they’re looking for, which is why we’re bring you the 2nd annual Cold Chain & Temperature Control Distribution Summit. This is the only online, interactive '‘information at your fingertips’ opportunity to temperature control pharma professionals.

Attend to:

  • Demonstrate temperature control and regulatory compliance – with regulatory presentations and updates on latest industry comments from the EMA and US Pharmacopeia
  •  Discussing the role of stability data  in addressing   temperature excursions and improving supply chain flexibility
  • Explore supply chain challenges and opportunities across the globe with regional expertise and spotlights on Europe, USA, Latin America, Russia, India and South Africa
  • Designing a robust security strategy; track and trace, anti-counterfeiting and theft concerns in emerging markets, RFID and serialisation
  • Collaboration!Ensuring compliance of third party contractors and developing a collaborative approach to your supply chain as a whole
  • Ask live questions and get immediate answers
  • Learn at your own pace and save money(no hassle traveling or finding hotels, no commitment to attending during limited times - this online event is spread over 4 weeks and recorded so if you missed a session it's there at your convenience to catch up when you are ready!)
  • Network with your peers via our private and exclusive LinkedIn groups (3800 + members) and share updates via our Twitter feed (2400 + followers) and Twitter event stream at #coldchainiq


WHO:

Temperature control logistics and QA professionals from all corners of the world will connect online to listen to industry best practices and international case studies.

  • No travel and accommodation costs inhibiting attendance. The Cold Chain online event offers delegates from multiple continents a convenient, low cost opportunity to learn across borders on international 'hot topics' and network in one platform.
  • There are no sales pitches, giving participants only real information that will help advance their cold chain practices.

WHAT:

The online cold chain event is the perfect accessible platform for cold chain professionals to understand the leading solutions, strategies and regulations in temperature controlled distribution from around the world. The online platform also allows us to bring together an unprecedented speaker panel from all of our around the globe giving insight into the "state of play" of cold chain in new markets such as Latin America, the Middle East, Europe, US and Asia Pacific. In addition, regulators from around the world will provide you with necessary compliance information to help establish global quality and regulatory processes and improve cost savings.


WHERE:

In the comfort of your home or office! No traveling expenses or timing conflicts. This online event takes place by using your computer or laptop and can be accessed live or at your convenience.


WHEN:

The event runs from June 26th to July 19th (spread over one month to decrease the time commitment per week). All sessions will be live, so you'll only have one chance to ask questions during Q&A. However, all sessions are recorded so if you can't make a particular session, don't worry, you'll have access to all 16 sessions to view at your convenience.

We will also be carrying on the discussion in our dedicated discussion group.


WHY:

Our aim is to connect the international cold chain community and disseminate best practices. Over the past ten years, IQPC has launched more than ten cold chain events covering regions from Latin America and the US to Europe and South Africa, developing some 74,000+ pharma cold chain contacts globally. With this experience behind us and reputed cold chain event brand, we are perfectly positioned to bring you the 2nd annual online Cold Chain and Temperature Controlled Distribution Summit.


HOW:

Simply register by clicking on any of the links throughout this page and you will be provided with access and log in instructions upon payment.



Agenda



Available
Now
Implementation of European Commission’s Revised Guidelines on Good Distribution Practice (GDP)
Riekert Bruinink

The EMA are due to release much anticipated updated GDP guidelines by the end of 2012. The industry comments on proposed updates have been collated and reviewed by the EMA GDP committee and a revised version is awaiting approval.

Riekert Brunink will provide an update on the industry feedback and insight into what some expected changed may be. Here’s a round up of what will be covered;

 

  • New requirements for wholesaler and distributors with special focus on;
  • Quality management issues
  • Procurement and storage
  • EU specific legislation
  • Operations and transportation
Speaker:
Riekert Bruinink, Group Chairman of the PIC/S GDP Working Group, Member of the EMEA GDP Draft, Dutch Health Care Inspectorate


 

Available
Now
Distribution within the USA; Export Requirements
Martha Kliss
  • Know your customer – compliance screening
  • Export compliance regulations EAR
  • Government agencies – BIS, OFAC, DEA, FDA, IRS
  • Is the commodity regulated by a government agency – DEA controlled, ITAR regulated, License required
  • Commodity jurisdiction – state, commerce, defence
  • Regional embargos and sanctions – Cuba and free trade agreements; NAFTA, CAFTA, WTO
  • Risk mitigation – IP protection, patents
  • Temperature controlled requirements – ensuring you have a plan B contingency plan
Speaker:
Martha Kliss, US Distribution, Import & Export Manager, UCB


 

Available
Now
CASE STUDY: Market Entrance, Customs and Logistics Challenges in South Africa
Lindsay Botham
  • Vaccine distribution in the national public health service: A case study
  • Understanding the vaccine distribution needs and demands in South Africa’s public health system
  • Implementing a robust and effective but efficient cold chain for vaccine distribution
  • Temperature monitoring and validation
  • Key concerns going forward and future directions
Speaker:
Lindsay Botham, Cold Chain Manager, Department of Health South Africa


 

07/03
9:15 AM EST
Optimising the Supply Chain Network in India and Beyond
Rajesh Pednekar
  • Assessing the implementation of the new cold chain regulation in India
  • Understanding local train, truck and warehouse cold chain facilities
  • Analysing documentation requirements and common pitfalls
  • Last mile cold chain transportation in India
Speaker:
Rajesh Pednekar, Head, Supply Chain, Pfizer, India


 

Available
Now
Designing a Quality Strategy for Cold Chain Supply in Latin America
Humberto Laserna
  • Understanding the risk of international and national cold chain distribution in Latin America
  • Developing training and planning strategies for all stakeholders
  • An overview of facilities and qualification
Speaker:
Humberto Laserna, Quality Coordinator, Pfizer Peru


 

Available
Now
Cool Chain Logistics Challenges in Russia & CIS – Finding the Way
Elena Adusei
  • Assessing the current state of cool chain logistics infrastructure in the region
  • Challenges & opportunities,  Janssen, Russia (practical examples)
  • Future – what to expect  
Speaker:
Elena Adusei, Supply Chain Director Russia & CIS, Johnson & Johnson


 

Available
Now
PANEL: What is Ambient and How can we Prepare for the Imminent Regulatory Expectations?
Lisa Mazzoni

Knowing what measures to take for ambient or controlled room temperature products is currently one of the industry’s biggest challenges. Regulators have eluded their requirement for more monitoring and control but we are yet to see any official guidelines.

 

This panel will provide an informal discussion for industry professionals globally,  where ambient can mean completely different things!  Take the opportunity to share ideas, ask questions and take the next steps to developing a strategy for your room temperature products. 

Speaker:
Lisa Mazzoni, Project Lead, Temperature Controlled Supply Chain, Roche


 

Available
Now
How to Use Stability Data to Address Temperature Excursions
Claude Ammann
  • Increasing flexibility through more effective use of stability data
  • Exploring methodologies for testing defining appropriate transport conditions based on current guidance
Speaker:
Claude Ammann, Director, Claude Ammann Consulting


 

Available
Now
The 2012 Time and Temperature Sensitive Roadmap
Andrea Graf-Gruber
  • From guidance to regulation – how has this been achieved?
  • Importance of standards – IATA development of a standard label
  • What are the challenges and how are these addressed?
  • The 2012 time and temperature sensitive roadmap
  • The way forward and future requirements
Speaker:
Andrea Graf-Gruber, Manager Business Process & Standards, International Air Transport Association (IATA)


 

Available
Now
Update on United States Pharmacopeia (USP) Final <1083> Guidance and Good Distribution Practices—Supply Chain Integrity
Dr Mary Foster
  • An overview of the USP Supply Chain Integrity Workshop
  • Industry vs. regulatory point of view
  • How to prepare your organisation for the changes to <1083>
Speaker:
Dr Mary Foster, Chair, Packaging and Storage Expert Committee, Unites States Pharmacopeia


 

Available
Now
Use of RFID in the Pharmaceutical Cold Chain
Jean-Pierre Ph.D. Emond
  • Preventing losses, protecting IP and ensuring patient safety through establishing a secure supply chain
  • An overview of RFID technology and tracking technologies
  • Effective use of RFID as temperature tracking technology
  • Effects of RFID on pharmaceutical products
  • Examples of applications in cold chain
  •  
Speaker:
Jean-Pierre Ph.D. Emond, Director, Cold Chain Research, Georgia Institute of Technology


 

Available
Now
Investigating the Risks and Potential Opportunities of Sea Freight
Paul Glossop
  • Investigating the risks and potential opportunities of Sea Freight
  • Auditing the reefers and carrier
  • Educating ocean freight supply chain stakeholders and partners
  • Beyond the technology: understanding ocean freight culture
  • Understanding risks in the lanes: the processes
  • Measuring quality parameters: plug in, plug out
Speaker:
Paul Glossop, Head of Logistics, Teva Runcorn


 

Available
Now
The Development of Global Pharmaceutical Logistics: Luxembourg's positioning
Daniel Liebermann
  • An overview of global pharmaceutical trends
  • Logistics hubs Luxembourg
  • Combining the assets of Luxembourg with current trends to develop an efficient pharmaceutical logistics hub
Speaker:
Daniel Liebermann, Director, Luxembourg Ministry of the Economy and Foreign Trade


 





How it Works



1. This online event showcases LIVE, real-time presentations.
From the comfort of your home or office, you can listen and watch the presentations in real-time and interact with the speaker and your peers that share similar challenges.

 

If your schedule isn't flexible to the LIVE presentations, don't worry; you'll get ALL sessions, on-demand so that you can participate at your convenience.

2. Interact with the presenters as well as logistics and QA professionals LIVE!

Unlike pre-recorded webinars, this event gives you the opportunity to interact with the experts in real-time. Presentations and discussions take place the moment you log on, and if you have questions or comments while the event is taking place…just ask and you'll get a response instantly!

The virtual rooms are equipped with many features that give you the ability to participate in surveys and polls, desktop sharing, downloadable content, live chat and live Q&A, amongst many other options.

3. Networking is a key contributor to knowledge sharing...

Often when you go to conferences, you exchange business cards with your peers. Usually the conversation stops once you pack up and head back to work…not here! This online event not only gives you the chance to meet like-minded professionals that are in the same boat as you, you'll be able to have extensive discussions, live on going interactivity and continuous sharing of best practices.

Don't forget to join our LinkedIn Event group where you can network and continue to interact with logistics and QA professionals like yourself. (Our LinkedIn Group is open to all event registrants so that you can continue your experience of the event indefinitely, without being harassed by sales pitches and spam!)
 

Take full advantage of our event-focused Twitter-based chat stream (the hash tag for this event is #coldchainiq) where you can interact live with your peers while the event is taking place.


We understand that you don't have much time in your busy schedule, so we have designed this event to accommodate you as best as we can. We've expanded this online event over the course of 4 weeks, with a handful of sessions a week.

And if you can't make it, you'll have access to anything you missed! The recordings will be available for you to view at any time.





Let's Look at the Facts



Fact: Driven by regulations, more products are requiring temperature control handling from refrigerated to ambient to cold, broadening the cold chain market

Solution:
Transportation and packaging solutions exist for handling all temperature ranges. Shippers right now are working with supply chain partners and providers to design and implement cost-effective ambient solutions.

Fact:
Worldwide sales of vaccines are predicted to rise from $16 billion in 2007 to $35 billion by 2014, according to a report from Scientia Advisors.
Roth, G. Y., Outsourcing & Vaccines, Contract Pharma Magazine. Nov/Dec 2009. Rodman Publishing, Ramsey, N.J.

Solution: With increasingly limited air capacity and restricted logistics budgets to get life-saving medicines to distant regions, new solutions are needed. This huge growth of temperature sensitive vaccines is driving the development of novel technologies for transportation and logistics such as thermo stable vaccines, solar “battery free” refrigerators, “zero energy” cold chain electric vehicles and longer-term passive storage containers.





FAQ's



This event would be perfect for my colleagues; can I sign up and share my log in with them?
We understand the value of team learning and have structured the pricing to reflect this with significant group discounts. However, when you sign up, you are given a unique code, which is also tracked directly to your IP address. You will therefore not be able to share the access to your colleagues.


I can't make some of these sessions. Will I be able to get a copy?
Yes. This event is designed so that if you can't attend some presentations, ALL sessions will be made available on-demand so that you can view them at your convenience. Even if you do attend the LIVE sessions, you will get access to all the recordings to keep for your own use.
 

When are the sessions being offered?
The session timings are outlined next to the individual sessions above. They are all listed in EST, but remember to convert them to the time zone you are located in. Remember...if you can't make any or all of the sessions because of the time difference, don't worry; you will still get access to the recording so you won't miss a thing!
 

We know that some of these times might be early or late for you, depending on where you are in the world. Unfortunately, this is the price you have to pay for gaining access to such high quality speakers from around the world. The good news is that you won’t miss a minute, as all presentations are able to be viewed on demand at a time convenient to you.


Will the PowerPoints be available?
All registrants will receive a PDF copy of the PowerPoint slides prior to each session.
 

Where is the event?
The event is located from the comforts of your home or office. You face no hassle of travel or accommodation expenses!


How long is each session?
Each session is 1 hour in length. There will be a 15 minute break between each session that will give you the chance to network with those in your session and ask the presenter questions.
 

How do you ask questions during the sessions?
For LIVE sessions, the speakers and attendees are set up with LIVE chat, that way the speaker can directly address any questions you may have pertaining to their presentation. For on-demand sessions, you may visit our interactive LinkedIn Group for this event and catch up on anything you might have missed and ask questions of the speakers and your fellow peers.


Can I just buy certain sessions without purchasing the whole event?
Individual session sales are not available. The all-access pass gives you admittance to all 16 sessions plus all additional bonus materials. Not to mention the incredible networking opportunity that you will be able to continue post event.


What if I have technical questions or any other type of questions, who do I contact?
The online event has been designed to be extremely simple and easy to participate in, wherever you are in the world. In the unlikely event that you have any technical difficulties or any questions about the event, you may send an email to customer support at customerservice@pharma-iq.com or call us at +1 877-711-2986 and we will respond immediately to your inquiry.

 
Act now—and register yourself—and a team of key people today!
 





Check out the Early Bird Sale!!



THE FIRST 50 REGISTRARNTS GO FREE!

Apply now for your free place

 

If you learn just one strategy on how you can improve your company's temperature controlled activities, the investment in your professional development will have paid for itself.

Register today and take advantage of this great savings!

Still have questions? Call us at +1 877–711-2986 or email us at customerservice@pharma-iq.com and we will respond immediately to your inquiry.

This unique opportunity gives you the chance to learn from the industry's most knowledgeable experts.


Act Now and secure your spot today!





Maximise Your Involvement: Sponsorship and Exhibition Opportunities

 

The Online Cold Chain and Temperature Control Distribution Summit provides an accessible platform for the cold chain community to assess the latest regulations, customs requirements and temperature control strategies. The addition of the online platform allows us to bring together a truly global audience who might not be able to make our real world events, as well as an unrivalled speaker faculty!

Focused and high-level, the event is an excellent platform to initiate new business relationships, launch a new product or raise your profile amongst new markets.

Sponsorship options are extensive, and packages can be tailor-made to suit your individual company's needs. Packages can include complimentary registration, targeted marketing and a featured presentation on the programme

 

Other features of sponsorship include:

• Live and on demand webinars

• Participation in comprehensive pre-event marketing campaigns

• Inclusion in our event focused social media strategy

• Inclusion on the Pharma IQ portal (+50,000 members)

• Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirements

 

Who Will Attend?

Directors, senior managers and managers within pharmaceutical and biotech manufacturers with responsibility for:

  • Logistics
  • Temperature Control
  • Supply Chain
  • QA


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Register for this Online Event


 

 

Pricing

 

Earlybird 1
Register before
30 March 2012

 

Earlybird 2
Register before  25 May 2012
Standard Rate
after 25 May 2012
1 Person $49 $99 $199
Groups of 3
(per person)
$49 $89 $149
Group of 5+
(per person)
$49 $79 $129
Group of 10+
(per person)
$49 $69 $109


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Each license is for a term of six (6) months, beginning on the date on which the online event starts, unless another term is specified in the booking confirmation. Access to the event (i) is restricted by IP address to one user per registration; (ii) is intended only for each registrant's individual use; and (iii) may not be shared with other persons or entities, either internally or externally. Should the client attempt to exceed the scope of the license, the client acknowledges that IQPC reserves the right to any course of action up to and including the invoicing the client for non-authorized access and seeking of damages against the Client.

About The Organizer

Pharma IQ (www.pharma-iq.com), a division of IQPC, is an international online community focusing on providing pharmaceutical professionals with knowledge, information and articles. We are dedicated to creating a learning environment for sharing ideas, best practices and solutions within the pharmaceutical community

Through Pharma IQ, you will be able to access pharmaceutical information resources such as presentations and podcasts, as well as events such as webinars, seminars and conferences.

By signing up to the Pharma IQ membership, you will gain access to our growing database of multimedia presentations from leading pharma practitioners, weekly newsletters to keep you updated on latest pharmaceutical content and Pharma IQ members-exclusive discounts on pharma events that offer solutions to your everyday business problems.

Pharma IQ and IQPC provide useful training courses, conference and expositions for pharmaceutical executives to network and learn the latest pharma business development and trends occurring in organizations today. Pharma IQ focuses on establishing an interactive experience featuring practical, objective and up-to-date insight from pharma industry leaders.













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Riekert Bruinink

Dutch Health Care Inspectorate

Riekert Bruinink was awarded a MSc degree and a PharmD degree by the University of Utrecht, the Netherlands. From 1981 until 1987 he worked as pharmasist in several public pharmacies. In 1987 he joined the Drug Inspectorate and in 1995 the Health Care Inspectorate in the Netherlands. Riekert Bruinink held various positions , including management positions. He is now a GMP/GDP Senior Inspector and specialised in Good Distribution Practice. He is chairman of the GDP working group of the PIC/S since 2007 and from december 2008 member of the EMA GDP drafting goup. This group is responsible for making a proposal for a new EU GDP Guide and procedures for harmonising GDP inspections in the European Union.

Speaking on: Implementation of European Commission’s Revised Guidelines on Good Distribution Practice (GDP)

 

Martha Kliss

UCB

Martha Kliss has held multiple roles through various company mergers and acquisitions during her 19-year Pharmaceutical experience. Her diverse core responsibilities include: International Relations, Import & Export Compliance, International Policy, Financial Reporting and most recently under her current role with UCB, Inc., as the Distribution and Import/Export Manager; she is accountable for the Transport and Distribution of temperature controlled bio-technology products, and traditional Rx pharmaceutical portfolio. She has been an active member of the US Chamber of Commerce and through its International Business Council (Rochester NY-Chapter) has held various positions including President of the Advisory Board during the 2005 term. Martha is also a member for the Upstate NY District Export Council where she has remained an active member through two consecutive terms. During her professional journey she has presented International Trade Business and Compliance topics to local NY Colleges such as ‘How to Evaluate & Promote your Portfolio in Latin America”, ‘Doing Business in Foreign Cultures’, ‘Export Compliance 101’, etc. Martha has a bachelor degree in International Commerce from the Instituto Politecnico Nacional in Mexico City.

Speaking on: Distribution within the USA; Export Requirements

 

Lindsay Botham

Department of Health South Africa



Speaking on: CASE STUDY: Market Entrance, Customs and Logistics Challenges in South Africa

 

Rajesh Pednekar

Pfizer, India

Topped SSC Merit List in Science of Maharashtra State ,B.Tech in Engineering, Research at IIT - Bombay ,MBA (Operations) from NITIE – Mumbai, Regional Logistics Manager for ICI (Paints), Head – Logistics for Nutricia (India), Global Supply Chain Manager (Pharma) for GS Pharmaceuticals Group Plc UK, Head – Distribution, Supply Chain for Nicholas Piramal, General Manager Supply Chain for NITCO Tiles, Head – Supply Chain for Novartis Pharma and recipient of Excellence in Supply Chain Award for Asia Pacific during the tenure for two consecutive years of 2008 and 2009, Currently Head – Distribution for All Legal Entities of Pfizer Group in India and have achieved about 48% reduction in Out-bound Supply Chain costs for Pfizer’s Human Health Business in last 3 years. International Speaker and Presenter in Supply Chain & Cold Chain Conferences in APAC. More than 16 years experience in Logistics, Supply Chain and Cold Chain with leading companies in FMCG, Pharma, Food and Nutraceuticals with strengths in Logistics, Supply Chain , Inventory Management, Distribution, Warehousing & Transportation 3rd Party Purchase & Procurement, Forecast Accuracy Improvement, Customer Services, Commercial and Sales Administration , Sales Tax and VAT, Fast track Set up of cost effective and compliant Pan - India Cold Chain Infra-Structure at CFAs in the shortest possible time, Supply Chain Mergers and Acquisitions – especially CFA Integrations, Business Divestment and Technological Transfers of Pharmaceuticals products across continents. Exposure to SAP and i2 environment. Successfully handled 3500 + SKUs in Paints, 1200 + SKUs in Pharmaceuticals, 70 + CFAs, 7 CSA s, 7 Distribution Hubs (Sales and Samples Hubs)

Speaking on: Optimising the Supply Chain Network in India and Beyond

 

Humberto Laserna

Pfizer Peru

Humberto has gained 7 years of experience in quality system, cold chain process and project of continuous improvement, during his previous position as quality assurance inspector at Wyeth Pharmaceutical. His current position is a quality coordinator and Pfizer, based in Peru. He holds extensively knowledge in the different worldwide tendencies in cold chain in USA, Europe and Latin-America and has experience in maintaining the cold chain in places without electricity, available roads and extreme weather. Knowledge about ISO 9000, PMBOK, Six Sigma, 6S, Poka Yoke, Risk Management and all the activities regarding to Good Manufacturing Practices including validations. Red Belt and Trainer Certification.

Speaking on: Designing a Quality Strategy for Cold Chain Supply in Latin America

 

Elena Adusei

Johnson & Johnson

Elena Adusei is supply chain accomplished leader with efficient change management skills and 8?years track record of inspiring teams and delivering significant results in highly regulated markets environment. Currently Elena holds position of Supply Chain Director Russia & CIS of Janssen, pharmaceutical division of Johnson & Johnson. She is council of cross?sector supply chain of J&J, Russia (Janssen, MD&D, Consumer, Vision Care). Elena has more than 15 years of wide range of supply chain experience in various companies including GlaxoSmithKline HealthCare, Novartis Consumer HealthCare, Varta Geretebattery GMBH, Apteka?Holding etc. She holds Master Degree in marketing from the Institute of Finance & Economics. She is APICS (International Association of Operations management, USA) member. Her area of interests is performance activities, master of ceremony, public speaking and singing. She is awarded for “great teamwork”, “person who creates the mood”.

Speaking on: Cool Chain Logistics Challenges in Russia & CIS – Finding the Way

 

Lisa Mazzoni

Roche

Lisa Mazzoni has over 20 years of supply chain experience in the pharmaceutical/biotechnology industry. In 2006, she joined Genentech in San Francisco USA to direct its multi-distribution center operations, shipping primarily cold chain products. There she initiated a Cold Chain Committee and subsequent Key Focus Area around the temperature control distribution process. In 2009, she accepted a position to move to Roche global headquarters in Basel, Switzerland where in March 2010 she took over responsibility for the global project for Temperature Controlled Supply Chain. The global project focuses on all temperature conditions for all material and product movements throughout the company. Activities include development of metrics, excursion tracking systems, and packaging solutions (including qualification). Ms. Mazzoni holds a BA from Harvard University (Cambridge, Massachusetts, USA) and a MS in International Logistics from Georgia Institute of Technology (Atlanta, Georgia, USA).

Speaking on: PANEL: What is Ambient and How can we Prepare for the Imminent Regulatory Expectations?

 

Claude Ammann

Claude Ammann Consulting

Claude is Managing Director of Claude Ammann Consulting, a company to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities. He holds a Ph. D. in Sciences from the EPFL, Lausanne, Switzerland and has over 25 years of experience in the Pharmaceutical and related industries. Claude built his industrial experience at Zyma and Ciba-Geigy, both now part of the Novartis group. He started as Manager of Zyma’s HPLC laboratory. Then he served as QC Director and QA Director for the company’s global self-medication sector. His career was given new depth by switching to production as Director Production of Novartis's Nyon site. He later became responsible for site management and QA organization at Valibio, a company focused on recombinant DNA production of clinical trials drugs for third party companies. There he managed projects from the drawing board up to preparation for Swissmedic certification. In May 2003 Claude joined Apoxis, an R&D firm in the oncology segment, as QA/QC Director. In June 2007 Apoxis was taken over by TopoTarget A/S Denmark, an international biotech company dedicated to developing improved cancer therapies. Claude was Site Manager and Director of Quality Assurance / Quality Control for TopoTarget Switzerland SA, based in Lausanne (Switzerland). He has been Responsible Person as qualified by Swissmedic. In 2009 he started his own business to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities.

Speaking on: How to Use Stability Data to Address Temperature Excursions

 

Andrea Graf-Gruber

International Air Transport Association (IATA)

Mrs. Andrea Graf-Gruber joined the International Air Transport Association (IATA) in 2008 as Manager Business Process & Standards in the Cargo Division and is responsible for delivering the electronic document standards for the air cargo supply chain, including the development, maintenance and promotion of the standards to additionally support the IATA e-freight project. Mrs. Graf-Gruber has as well taken over the responsibility of managing the IATA regulations related to the transport of Live Animals and Perishables Cargo. Mrs. Graf-Gruber is secretary to the IATA Live Animals and Perishables Board and the Time and Temperature Task Force and is in that respect, cooperating with international organizations, such as CITES and the OIE. Prior to working with IATA Mrs. Graf-Gruber joined in 1997 the International Road Transport Union (IRU), where she began her professional career in the transport industry. As head of a division she implemented, at the Customs and business level, tools to assist the application of risk management, allowing Customs’ electronic data exchange in real time and ensuring the sustainability of the TIR Customs Transit system. Mrs. Graf- Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.

Speaking on: The 2012 Time and Temperature Sensitive Roadmap

 

Dr Mary Foster

Unites States Pharmacopeia

In May 2011, Dr. Foster began working with Aphena Pharma Solutions as the corporate VP Quality and Regulatory Affairs. Aphena is a contract pharmaceutical manufacturer and packager. Prior to this she was the VP Quality for Catalent, also a contract pharma manufacturer and packager. Mary is a regulatory/quality professional with 27+ years’ experience in human pharmaceutical /biotechnology, veterinary and OTC monograph products; dietary supplements/nutraceuticals/foods; medical devices and cosmetics all in one or a combination of regulatory compliance, regulatory affairs, quality control and quality assurance capacities for manufacturing, packaging, holding and transportation of product encompassing global operations. Progressive experience in manager, director and current vice-president leadership roles within a multi-cultural diverse staffing in this industry with experience in oral, sterile, packaging and printed component businesses. Dr. Foster is the Chair of United States Pharmacopeia (USP) 2010-2015 Expert Committee on Packaging, Storage and Distribution of drug product. Expertise in USA FDA drug current good manufacturing practices (cGMP) and device Quality System development and implementation; in-depth experience with Canadian, South American countries and EU cGMP; and, interface with Australia and Japan in development of compliance programs. Subject matter expert in creating and maintaining compliant regulatory USA Drug Enforcement Administration (DEA) environment. Development of two stand-alone laboratories within the pharmaceutical industry (1990 and 2000). Responsible for creation of Quality Management System development for new company formed from divestiture and, responsible for developing connections within the industry and worldwide regulatory bodies to ensure a current understanding of regulatory compliance is in place and an improvement process is continuous for quality processes. Holds BS and PharmD degrees from the University of Kentucky and BFA from Western Kentucky University.

Speaking on: Update on United States Pharmacopeia (USP) Final <1083> Guidance and Good Distribution Practices—Supply Chain Integrity

 

Jean-Pierre Ph.D. Emond

Georgia Institute of Technology



Speaking on: Use of RFID in the Pharmaceutical Cold Chain

 

Paul Glossop

Teva Runcorn

Paul heads the Supply Chain for Teva Runcorn, delivering sterile products to the USA and globally. He is introducing innovative policies to improve supply chain velocity, increase customer service and reduce inventory. A drug discovery chemist by academic background, Paul has delivered lean transformations in organisations ranging from Aerospace to major Pharmaceutical companies, and from Financial Services to Hospitals.

Speaking on: Investigating the Risks and Potential Opportunities of Sea Freight

 

Daniel Liebermann

Luxembourg Ministry of the Economy and Foreign Trade



Speaking on: The Development of Global Pharmaceutical Logistics: Luxembourg's positioning