Outsourcing Regulatory Affairs Training

at

ASTRA-ZENECA

A Case Study

The Challenge

At the end of 2008, AstraZeneca Regulatory Affairs Learning and Development made the
decision to outsource its regulatory affairs training programme, which had previously
been provided using internal resources. A Request for Proposal process was conducted
which ultimately saw RRG selected as the provider of choice for the training solution.

There were three separate courses, all three to be delivered in AstraZeneca facilities in
the US, Sweden and the UK:

Introduction to regulatory affairs - 1.5 days

European regulatory affairs 1.5 days
US regulatory affairs 1.0 day

The Clinical Learning and Development group in AstraZeneca had also identified
regulatory affairs training as a key training requirement for their staff. Regulatory Affairs
and Clinical Learning and Development departments worked together with RRG on the
development of the programme to meet both groups requirements. Examples of
functions represented on these courses include

Global regulatory affairs

Regulatory Operations
Submission management
Product labelling
Clinical development
R&D project management
Drug Safety
CMC regulatory affairs

The courses were delivered in the autumn of 2009. Due to the popularity of the courses,
the EU and US courses were repeated to clinical delegates in January 2010. In total,
approximately 550 delegates were enrolled onto the courses over this time (including
individuals attending more than one course module, e.g. EU and US courses).
AstraZeneca view on the success of the training programme

From AstraZenecas point of view, this training programme was an outstanding success.
The pre-course liaison with RRG was excellent and ensured that the programme was
tailored to our needs and met our predefined objectives. RRG managed the preparation
and printing of all course materials and these were delivered to the different training
locations on time on all occasions.

The quality of all the course material was also excellent. In particular, the course notes
were extremely valuable and very well received by the delegates, as evidenced by the
feedback comments received (delegate comments in italics in text below):

Excellent reference material that I will undoubtedly have benefit from for a long
time.

Great detail in the manual will allow future use as a reference guide. Useful
website/FDA references.

In our view these course notes are a unique feature of RRGs training offering, as they
provide added value as a reference document once the course is over, compared to
relying exclusively on copies of Powerpoint slides.

As well as high quality course notes and slides, an important component of each course
was the teamwork exercises. There were at least three teamwork exercises in each course
module which reduced the reliance on lectures and at the same time allowed delegates to
apply their new knowledge to practical situations. The vast majority of delegates felt very
comfortable with participating in the teamwork exercises and felt they added to their
learning experience.

Normally I dont like teamworks but these teamworks were really good!

Application workshops were a great way to apply lecture material.

The key to the success of the courses was however the expertise of the instructors. As one
delegate put it:

Both instructors were excellent, well informed and knowledgeable. Made what
could be a dry topic very interesting.

Indeed, the subject matter could be considered dry. However, the RRG instructors were
highly skilled in presenting the information in an engaging and interesting way. In
particular, their ability and willingness to supplement the information with real life
experience, within the confines of client confidentiality, was greatly appreciated by the
audience. The fact that all instructors were currently practising regulatory consultants,
actively involved in real world projects, made this all the more relevant.
All presentations very well delivered and presenters were able to support with
relevant example from their own varied experience.
 Both very knowledgeable, open to questions and willingness to discuss issues/give
examples.

Very engaged with lots of real life experiences which add value.

Very good course! It was extremely useful to hear it from people who actually work
with Regulatory Authorities and know their job and all the challenges.

The injection of humour, the differing delivery styles, the use of two instructors
alternating the delivery and the encouragement of the audience to ask questions and
provide their own experiences, further added value to the training programme.

Both very knowledgeable. Glad there were two instructors (a lot of work for one
person). Kept it alive and moving.

I really enjoyed the spirit and fun of the course. It made the material and subject
much more "user friendly". Thank you!

Both were very energetic and had a level of expertise about the subject.

A measure of the success of these courses is the demand from within AstraZeneca
regulatory affairs and clinical development groups for places on the course. RRG were
very flexible in repeating the courses early in 2010 to meet the demand from the clinical
group. Indeed, AstraZenecas willingness not to restrict this training programme to
regulatory affairs staff but to include clinical, project management, drug safety and other
groups was greatly appreciated by the delegates. The RRG instructors commented that
they felt that the clinical and other delegates would benefit enormously from an
understanding of the regulatory environment for the products they were developing or
managing and that this would be of great use in helping them manage their day to day
activities.

Very good course, thank you! Thank you for opening up the course for non-
regulatory employees at AZ.

In conclusion, the experience AstraZeneca has had in developing and delivering a

comprehensive regulatory affairs training programme with RRG has been extremely
positive. All the courses were very well received by delegates and met the predefined
learning objectives. The whole programme was managed very efficiently by RRG, in
collaboration with AstraZeneca staff, and was delivered to budget. We believe that the
outsourcing of our regulatory training programme to RRG has achieved the objectives we
set ourselves of delivering a high quality programme to budget and on time. The
advantages of outsourcing this training rather than provide it from internal resources
include reducing internal time and resource constraints but also providing an alternative,
outside view of the subject matter, which can confirm but also supplement our own in-
house experience.
 I think it was a well structured and delivered programme. The fact that it was
delivered by a company external to AZ is very positive as it gives us a wider
experience and useful examples. It also allows us opportunity to ask questions and
use the experience.

We plan to repeat these courses later in 2010 and thereafter and would without hesitation
recommend RRG as an excellent provider of in-house regulatory affairs training for other
companies with similar needs to AstraZeneca.

Kristin Lindahl Birgitta Lyrdal

Global Head Learning & Development Partner Lead

Global Regulatory Operations Clinical Learning and Development
AstraZeneca AstraZeneca