Find out how Regulatory changes and pressures are being tackled across Europe. Within a dynamic regulatory environment, where failure to comply impacts patient safety and product approval status, what needs to be considered when building a specialist work force? View the PPT to explore more on: - Leadership initiatives to engage and manage the specialist labour work - Measures to ensure scability in a limited talent pool - Considerations when implementing multi-site or international projects

1. A whitepaper on preparation,
anticipation, remediation
Regulatory & Notified
body response:

2. Within an evolving, dynamic landscape,
where precise submissions and responses
are demanded, it can be reassuring to
know our individual consultants and
project teams understand commercial
objectives and deliver technical expertise.

3. Real understands that a quick, accurate response to a regulatory or notified body is necessary
to ensure your products continue to improve the lives of patients.
This has been demonstrated by our response to a customer’s request for support.
Situation

4. A global healthcare organisation was issued with a number of
warning letters in connection with their products in a particular
therapy area.
Owing to a succession of compliance issues identified, the
organisation required reviews of validation, processes, software,
computer systems, CAPA and quality processes themselves.

5. Updates were necessary for some documentation: root
cause investigation, complaint handling and training.
Agreements were made with the Regulatory body as
actionable follow up to be initiated by the organisation,
meaning a significant up-scale of specialist labour would
be necessary.

6. Scale:
The provision of a large scale consulting project within a specific therapy area carries a
number of intrinsic complexities.
A significant quantity of technical experts, numbers going into the hundreds were needed.
Background

7. However the talent-pool was already stretched.
This pool is fundamentally limited, as there is no way to
instantly train or develop expert-level skill-sets within
Quality, Regulatory or Compliance.

8. An unfortunate industry wide trend of product failure and recall
in this therapy area had entailed other organisations
programmes placing pressure on talent supply chains, making
up scaling the consultant workforce an ambitious proposition.

9. Solution
Real immediately understood the regulators actionable development points would require
significant Consultant force.
An Account Manager appointed a Delivery team to source talented Consultants in this area.
Real’s delivery team is unique in its focus: each delivery team member works exclusively,
100% FTE, on building a Consultant network across a specific skill set.

10. The outcome of this structure was that the Delivery
team was already in possession of talented
Consultants within a small talent pool.

11. 7 offices across Europe, with over 120 fulltime
staff working on the sourcing of talent in the life
sciences, equipped Real with the market
presence required to upscale under difficult
circumstances.
Our Delivery Team on boarded more internal
resource as the upscale requirements
presented themselves.

12. The outcome was that Real provided over 60% more
Consultants than the organisation’s second placed Consulting
partner allowing the customer to have confidence in their
reconciliation plan.

13. Diversity
Secondly, the organisations production and quality management facilities were spread across
many sites and in numerous countries.
Any model for supporting the issue reconciliation in a useful, holistic manner could not ignore
the idiosyncrasies of Consulting in these diverse regions, cultures, social and legal
environments.

14. The consultants and project teams put in place must
have correct language skills, awareness of cultural
practice and must themselves be compliant with local
labour-laws.
An end-to-end solution must recognise and manage
these variables; any service addressing only one
location, would be less efficient and
counterproductive to the organisations own efforts to
manage and direct the programme.

15. Solution
Real placed Consultants and permanent staff at over 1000 organisations in 14 countries in
2014.
We have 17 years of Consulting experience within the Life Sciences, working with small start-
ups, global healthcare companies, their service providers and surrounding institutions.
Our status as a publicly listed firm (LSE: FTSE250) ensures we are legally obliged to deliver
our services in a risk-assured and compliant manner.

16. Our Delivery team’s specialisation means we have developed
a deep understanding of each of the cultures, languages,
regions and legislation of the regions we operate in.
By delivering our Consultants through a broad network of
offices, we used the accumulated experiences of previously
placing Consultants in these areas.

17. This meant that our Consultants were always able to
start onsite, no matter where, and were equipped
with the appropriate cultural awareness, experiences
and language skill sets to immediately meet the
organisation’s challenges.

18. Management, Engagement & Direction
Scale and complexity can sometimes also entail longevity.
Consultants were engaged for an average of 15 months in order to see through and complete
the full burden of work.
Over a longer consulting period the team must be engaged, offer stability and consistent
presence of intellectual capital.
Unstable teams lead to time-lost through on boarding, training and familiarisation of Consultants,
as an empty seat must be filled by a new Consultant.

19. In parallel to the soft-human aspects, the organisation
required hard-structures in place, through which they would
be empowered to objectively understand, manage and direct
the consultant force.

20. Solution
Real’s Account Management team consisted of a single point of contact for all operational
queries and a senior member of the European Leadership team for initial escalation.
A fail-safe escalation point was nominated in one of our Executive Board members ensuring
that any requests or feedback would be listened to.

21. A broader role of these meetings was to perpetually
benefit from insight into the organisation’s performance
expectations and organisational culture.
Real’s experience enabled them to adapt their service to
pre-empt the organisations requirements, amplifying the
management and leadership’s savings.

22. Management structures were setup with the Consultants,
which included periodic meetings, performance appraisals and
welfare checks, in addition to clear on-boarding support, which
reduced the time from Consultant hire to productivity.
The result: 98% project completion and 96% of Consultant
extensions were accepted.

23. Conclusion
The preparation, anticipation and remediation of Regulatory or Notified body action is a
business critical concern which ensures patient safety; but at its most extreme can bring
product lines to an end.
Patient safety, product quality and process excellence are inseparable entities which demand
effective, stable and precise Consulting solutions.

24. When executed well, organisations will benefit from efficient
and effective impacts in patient safety, business capabilities
and improved relations with inspecting bodies.
Real has a track record of delivering industry-leading
Consultation, which can take account of scalability, diversity,
and is proactively managed to the client’s brief.

25. Who is Real?
- Real offers a complete suite of regulatory and
compliance consulting services to support
organisations in achieving or remediating
compliance with Regulatory and Notified bodies.
- From individual consultants, mock audits, project
teams to strategic outsourcing, we provide a
solution tailored to your requirements.
- Our suite of services allows a complete
outsourced delivery, consultants to fill workload
peaks and knowledge gaps or managers to
provide structure and direction.

26. About the Author
Gareth Rose has 10 years experience of Life Science staffing.
Since graduating in Dual Honours from the University of Sheffield, he
has won industry awards for his service levels in Life Science
staffing.
His international career has seen him work in the UK, The
Netherlands, Germany and Switzerland, leading and managing
delivery teams in each region.
He is currently Head of Service and Client Development within Real
and develops individualised solitions for customers.
Gareth‘s professional interests are performance excellence,
customer experience and strategy.
g.rose@realstaffing.com