Rx-360
An International Pharmaceutical Supply Chain Consortium
Rx-360 Supplier-Led Working Group
Overview
Presented by:
Rick Calabrese
Global Corporate Director of Quality Systems
Sartorius Stedim North America Inc.
Protecting patients worldwide
Background on Working Group
• Rx-360 supplier members are leading an initiative
through which they can share perspectives and work
collaboratively with manufacturer members to achieve
greater harmonization and efficiencies in the supply
chain and better serve patients.
• Gary Perkins (Sigma Aldrich) and Rick Calabrese
(Sartorius Stedim) serve as the Supplier WG Co-Chairs.
Rx-360 Supplier-Led Working Group
Members
Co-Chairs:
Rick Calabrese (Sartorius) and Gary Perkins (Sigma Aldrich)
Kim Ashmore (FujiFilm)
Tom Beil (Sigma Aldrich)
David Bricker (Eli Lilly)
Dick Chen (Amgen)
Bonnie Custodio (Amgen)
Rainer Fendt (BASF)
Brad Gunter (FujiFilm)
Linda Hayward (Merck KGaA)
Nina Heinz (LifeConEx)
Riitta Legros (Teva)
Bretta Lichtenhan (Merck KGaA)
Leslie Madigan ( Life Technologies)
Mireia Montull (VWR)
Patrick O’Meara (Forest)
Derek Parks (Merck KGaA)
Luisa Paulo (Hovione)
Raj Sheshadri (Novartis)
Rick Siberski (Avantor)
Eddie Thomas (Sartorius)
Marcella Turk (BMS)
Guy Villax (Hovione)
Cornelia Wagner (Bayer)
Lory Wikstrom (GE Healthcare)
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Role of Suppliers
• Rx-360 is a unique forum that brings together
pharmaceutical manufacturers and suppliers as
members
• Rx-360 members share a goal: to strengthen the
healthcare supply chain and protect patients
• Rx-360 supplier members see the consortium as
a constructive forum for suppliers to identify
greater efficiencies in the supply chain, and that
such a forum enhances the value proposition of
their membership
5
Organization & Scope
• Organization:
– Supplier-led initiative but open to all members
– Tackle one deliverable at a time
– Committed engagement by all members is an
expectation
• Scope of Activities:
– Developed Working Group Charter
– Identify deliverables that contribute to greater
harmonization and efficiency in the supply chain
• Near-term priority:
– Template Supplier Assessment Questionnaire (SAQ)
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Background on Rx-360 SAQ (I)
• Pharmaceutical manufacturers and industry suppliers
recognize the inefficiency and waste of resources when
each individual pharmaceutical company creates its own
supplier assessment questionnaire. Suppliers routinely
exhaust valuable resources continuously completing
slightly different forms of substantially similar
questionnaires.
• The Working Group analyzed numerous sample
questionnaires submitted by Rx-360 members.
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Background on Rx-360 SAQ (II)
• The Rx-360 SAQ covers standard information that would be
included in most supplier assessment questionnaires. The 3-part
questionnaire is more detailed than most, but will decrease the
number of times that questionnaires will need to be filled out by the
supplier, while significantly decreasing the turn-around time back to
manufacturers.
• The Rx-360 SAQ consists of four (4) modules:
– General Company Information
– Specific Site Information
– Product Supplier Appendix
– Service Supplier Appendix
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Background on Rx-360 SAQ (III)
• Each company using the Rx-360 SAQ will still need to interpret,
assess, and score the questionnaire as they have done with their
previous questionnaires.
• The Rx-360 SAQ is intended to make the collection of relevant
information more consistent and efficient. Individual companies are
still responsible for evaluating the questionnaires, determining any
risk to their products, and following up with suppliers for more
information as needed.
• The Working Group believes the Rx-360 SAQ will create helpful
efficiencies for both suppliers and pharmaceutical manufactures
alike by:
(i) Eliminating time-consuming redundancies
(ii) Streamlining the process of approving suppliers
(iii) Allowing comparative analysis of basic information.
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SAQ Roll-Out Process
•
•
•
•
The Working Group is currently working on promotional materials in support
of the public release of the SAQ.
– Press Release to announce launch of SAQ
– Host webinars to walk through use of the document and provide forum
for feedback.
Subteams are drafting topic-specific appendixes that will allow
customization to provide specific information regarding individual products
or specific services.
The group has been party to discussions with Rx-360 leadership regarding
supplier value and supplier incentives in Rx-360 and hopes to continue
involvement in discussions pertaining to suppliers.
Leadership would like to thank Rx-360 members for their comment and
input throughout the process. The group plans to continue outreach to Rx360 leadership and members to encourage broad adoption of the SAQ.
Question
The Rx-360 SAQ is intended to address the inefficiency resulting
from the diversity and continuous influx of questionnaires received
by suppliers.
Would your company benefit from decreasing the time spent filling
out questionnaires as well as decreased return time to
manufacturers?
1. Yes
2. No
3. No opinion
Question
Do you anticipate that your company will utilize the Rx-360
template SAQ as the standard form for assessing vendors?
1. Yes
2. No
3. Don’t know
Question
Which of the following, if any, would make your company more likely
to use the SAQ?
1.
2.
3.
4.
5.
Support or endorsement by other industry groups
Adoption by a larger number of suppliers
Greater indication of actual efficiency (i.e. faster response times)
Ability to add company name and logo to template
Ability to modify aspects of the template
Supplier Led WG Forthcoming
Proposed Deliverables
• Development of template quality
agreement(s)
• Development of standardized approach(es)
to change notification processes
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Questions
Contact:
Rick Calabrese
[email protected]
Gary Perkins
[email protected]