The go-live date of the EU-FMD regulations is creeping up quickly. Stada works with a wide variety of CMOs (+170) and had to devise its own implementation strategies in order to get our trading partners on-boarded. Meeting the deadline is not just critical; it will also provide STADA with a market advantage over less prepared competitors.

1. CMOs critical assessment to de-risk product supply
in the view of EU FMD implementation
Marcelo Costa – Global Program leader
ManuPharma 2018
Frankfurt am Main, 5th December

2. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
The approach
Where we are / takeaways
The challenge
Agenda
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3. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
The approach
Where we are / takeaways
The challenge
Agenda
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4. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
The scenario
by end of 2017, with 14 months for Stada to meet the FMD deadline
EU FMD deadline
is 9th February 2019
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5. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
CMOs onboarding
meeting the deadline is not just mandatory; it will also provide
STADA with a market advantage over less prepared competitors
# of SKUs at CMOs: ~ 5.0002
# of CMOs: 135
# of onboarding: 162
# of purchasers: ~ 35
Total spend1: EUR +XXXMM
# of CMOs technically
connected in ‘17: 2 (1%)
Key figures
60%
40%
Global
Affiliates
Responsibility (# of CMOs)
However, execution in a high complex / challenging environment:
 5.000 of FMD SKUs produced by 135 CMOs in 162 plants
 Managed by 22 sales affiliates, covering 28 countries
 High pressure to avoid costs increase, thus delaying on-boarding
 Decentralized organization vs. global deployment:
- products planned and procured globally / locally
- artworks executed globally / locally
- CMOs producing goods for different affiliates, but one affiliate having to
negotiate on behalf of the other ones
1 Total yearly spend 2 Excluding Greece, Italy, and Switzerland (only selected SKUs)
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6. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
The approach
Where we are / takeaways
The challenge
Agenda
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7. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018 7
Risk Management
minimize supply risk from CMOs through risk-based decisions
Identify in-scope
SKUs and
suppliers –
eliminate non-FMD
suppliers, combine
subsidiaries,
eliminate out of
scope countries
SKU scope, on-
boarding progress
and commercial
status captured via
Steering List and
Tracking Tool
Develop “red-flag”
guidelines for
commercial
negotiations
Develop risk
assessment criteria
for 5 areas: general;
manufacturing/equip
ment; connection;
artworks;
commercial
Define list of
possible mitigation
actions
Develop risk matrix
for impact/
complexity based on
annual spend and
number of SKUs
Provide further
information on
artwork and IT
progress to inform
assessments
Calculating risks:
Global and local leads
rate each CMO using
guidelines
Risk identification
Risk Assessment / Impact
Iteratively review
Conversion of data
into knowledge
Identification of
mitigation actions for
high-risk
Risk Mitigation & Control Risk Communication
Sharing best practice
Fine-tune the concepts
Implementation of
actions
Risk acceptance
Monitor progress,
Re-evaluate risks

8. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018 8
Risk Assessment
indicative ratings
Risk Rating General Technical Connectivity Artwork Commercial
5
responsive, very well
informed on FMD,
mutually agreed plan
and meeting milestones,
generally reliable
supplier
single (or all lines on
all sites) FMD ready;
already producing
serialized product
PQ completed with
STADA Arvato CSDB
system
all SKUs FMD
ready
agreed no price
increase; or agreed
increase within
guidelines
4
plan agreed and
milestones being met;
no apparent supply risk
or not needed till mid-19
producing FMD-
compliant product on
at least some lines
technical connection
(gateway configured)
Most / many
SKUs ready or in
ePP system; few
SKUs to consider
close to in principle
agreement
3 agree plan in place
able to advise
equipment to be
installed on FMD
lines
not yet technically
connected, however
planned
pilot complete;
others underway;
no unresolved
issues / special
cases
no request for
increased prices yet
2
Awareness of FMD
however lack of priority.
Planned dates appear
too late. Lack of
confidence.
apparent delays; at
least some lines
without agree
solution/ equipment
bespoke system or
unknown to Arvato
only pilot
commenced;
unresolved
issues;
significant
packaging
changes required
significantly away
from red-flag
guidelines
1
poor supplier; little FMD
awareness; severe risk
on the supply of FMD
product
no lines ready,
installation behind
plan
not yet chosen L4
system; bespoke
system late
no artwork
changes started;
no ePPs; no
spec information
commercial
impasse; large
unjustified increase
Moderate Risk
Major Risk
Minor Risk
countermeasures
mandatory
countermeasures
recommended
closer control
acceptable

9. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018 9
Risk Impact
by risk rating and impact identifies more critical CMOs
Lower impact
lower spend and/or
few SKU #s
Higher impact
higher spend and/or
higher SKU #s
Higher risk
Grade 1
Lower risk
Grade 5
Each point is a
CMO

10. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
OD TC OQ PQ
Commer
cials
PSKU
PSKU
Artwork
PQ DateCMO
Onboarding Progress
Risk
xxxxxx 03/08/2018 Not started No info n/an/aCZ High
xxxxxx 31/08/2018 Tech Issue No info n/an/aNL High
xxxxxx 17/08/2018 Not Started No info n/an/an/a High
xxxxxx 16/08/2018 Planned No info 01/11/2018n/aDE High
Stock pilling
xxxxxx 19/09/2018 Mfg. Issue No info 01/01/2019n/aDE High
xxxxxx 26/04/2018 Tech Issue No info 14/12/2018No changeAT High
xxxxxx Confirmed DE n/a n/a05/09/2018
xxxxxx 25/09/2018 Not Started Negotiation DE n/a 02/01/2019 High
High
Risk Control / Communication
Mitigation actions and Risk dashboard
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11. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
The approach
Where we are / takeaways
The challenge
Agenda
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12. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
Where we are
Great progress, but important steep wall due to CMOs late readiness
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 157 Technical Connections
out of 162 concluded
 88 OQs completed, 66 OQs
still to be completed
 15 PQs completed so far
driven by “real” orders /
stock level managed in a
4-week rolling plan

13. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
 We cannot make clear decisions from dirty data
- Misleading decisions, waste of time and energy
 Culture does eat Strategy for breakfast1
- Top down escalation in order to get things done
- CMO on-boarding led to increased workload (to capture factors,
confirm, compare, prioritize, etc.), some purchasers tended to
trigger actions (e.g. stock build up) without properly challenging
CMOs or internal departments (e.g. artworks)
- Different meanings of risk, which is a cognitive and emotional
response to the expected loss (vs. uncertainties, pressure, etc.)
 Does the “risk rate” tell the truth?
- There is no “Zero” risk!
- Recognize risks at a desired level
- Risks are not static
- Keep enough data set for further evaluation!
Key Takeaways
Risk assessment and control proved to be key for us, however…
1 Adapted from the original: “Culture eats strategy for breakfast” by Peter Drucker
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14. PageCMOs critical assessment in order to de-risk product supply │ ManuPharma 2018 │ 5th September 2018
Thank You for your attention!
I will be very glad to
keep in touch with
You on
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