Reprinted from
PHARMACEUTICAL ENGINEERING
president’s message
The Official Technical Magazine of ISPE
January/February 2013, Vol 33, No 1
©Copyright ISPE 2013
www.PharmaceuticalEngineering.org
The Year Ahead: New Initiatives to
Achieve ISPE’s Mission
Berg reviews what’s on the horizon in 2013, including surveys, relationshipbuilding, technical study initiatives and new events that will position the Society to
become the leading technical organization for professionals engaged in producing
quality medicines and pharmaceutical delivery devices throughout the lifecycle.
T his is a great time to
be a part of ISPE. Not
only are ISPE Members leading some of
the most sophisticated
drug development and
production in the history of our industry, they are setting
benchmarks for quality and technology that were previously unimaginable.
It is a privilege to work with such a
distinguished Membership.
In 2013, as part of ISPE’s new mission to be the leading technical organization for professionals engaged in
producing quality medicines and pharmaceutical delivery devices throughout the lifecycle, we are undertaking a
number of new initiatives that include
surveys, relationship-building, technical study initiatives and new events.
These initiatives will demonstrate the
leadership and technical capabilities
of the ISPE Membership globally,
provide opportunities for involvement
by Member segments that are growing or underrepresented, and raise
awareness of ISPE among Members,
their companies and regulators worldwide. The efforts described below are
just a sampling of ISPE work that is
intended to help the Society be better
positioned to deliver Member value
through greater awareness of industry
needs and greater involvement in the
global regulatory landscape.
One of ISPE’s important new
initiatives is focused around the very
complex and multi-faceted issue of
drug shortages. An executive-level
ISPE Member team is spearheading
development of a survey to determine
the root causes of drug shortages; this
will help industry and regulators shape
a risk-based approach to preventing or
alleviating these events. The findings
will also help leaders explore whether
and how manufacturers could respond
to a drug shortage within a short timeframe. This effort has the involvement
of the International Leadership Forum
(ILF), major companies (including
companies that have been involved in
some aspect of drug shortages to date),
global health authorities including
FDA and EMA, as well as associations
such as EFPIA, EGA and others. The
ISPE survey findings will be presented
to FDA for use in responding to the
Food and Drug Administration Safety
and Innovation Act (FDASIA). This
survey will be completed by May of
2013.
In 2013, ISPE will also continue
its involvement in discussions and
education around the implementation
of Quality-by-Design (QbD) and will
be working even more closely with
regulators in this area. To that end,
ISPE will manage a new event focused
on the state of QbD being planned for
10-11 April 2013 in San Francisco, CA
(USA). Leading the effort are members of the Product Quality Lifecycle
Initiative (PQLI), a special interest
technical group within the Society.
In 2013, ISPE will also create a
number of new technical discussion
groups in response to Member and
industry input. For example, we will
form an exploratory group to discuss
Medical Device Security and a new
executive forum to discuss Clinical
Supply Logistics. We are seeking input
from Members interested in these
areas -- write to us about potential
participation opportunities (nberg@
ispe.org). These are two of many new
groups that will complement our
existing Communities of Practice.
It is ISPE’s intention to consistently
explore evolving areas that serve segments of our Membership that have
previously been underrepresented or
that could present growth opportunities aligned with ISPE’s mission.
All ISPE Members received the
2013 schedule of events postcard in
December that highlighted a number
of new ISPE conferences. In 2013,
ISPE is introducing several “intensive”
PHARMACEUTICAL ENGINEERING
January/February 2013
1
president’s message
events — smaller conferences with more focused technical content. For example, in addition to the QbD event
described above, we will host a new Proactive Compliance
Conference in New Brunswick, NJ (USA) in October; a
Lean Manufacturing Conference in Berlin, Germany, also in
October; and we will continue to “Redefine the ‘C’ in CGMP”
at the second ISPE-FDA event this June in Baltimore, MD
(USA). If you notice a theme in these programs (hint: quality and best manufacturing practices), you will certainly be
interested in the 2-3 April program entitled “Executive Forum: Best Innovation & Quality Practices from Non-Pharma
Industries” where experts from the automotive, aerospace
and food industries will present some of the most innovative
quality and manufacturing processes utilized in their industries to an audience of ISPE delegates. Many other events
and meetings are listed on our website at www.ispe.org.
ISPE’s mission is focused on being the leading technical
association for the industry. Through Member involvement,
surveys, programs and networking, we achieve our mission
and support the industry in delivering better outcomes for
our patient customers. I look forward to your feedback on
these or other ISPE initiatives. Even better, if you have an
idea for enhancing the value of ISPE, please let me know.
Register
Today!
ISPE 2013 Conferences
Don’t miss these topic
specific Conferences!
Critical Utilities Intensive: Cost-Optimization
Alternatives for Critical Utilities
25 – 26 February • Tampa, Florida USA
12 – 13 March • Copenhagen, Denmark
This two-day intensive education program will utilize case studies and
interactive sessions to illustrate alternative strategies for cost-effective,
risk-based approaches to design, construction and maintenance of
Pharmaceutical Water Systems, Ozone Sanitization of Pharmaceutical
Water, HVAC and Process Gases.
Visit www.ISPE.org/2013CriticalUtilitiesConference or
www.ISPE.org/2013-Critical-Utilities-EU-Conference to Register!
Aseptic Conference: Barrier Isolation,
Innovations in Aseptic Technology,
Cleaning and Sterilization
4 – 5 March • Baltimore, Maryland USA
Learn the latest in aseptic processes, including making disposables
work for your process, the latest in barrier isolation and containment
technologies, cleaning and sterilization. Regulators and users will
present state of the art developments in sterile process improvements,
risk mitigation, cost-effective processing and innovative applications
while providing attendees with practical knowledge that can be applied
to your operations immediately.
Visit www.ISPE.org/2013AsepticConference to Register!
2013 Upcoming Conferences
Executive Forum: Best Innovation and Quality Practices
from Non-Pharma Industries
2 – 3 April • Philadelphia, Pennsylvania USA
The State of QbD in the
Pharmaceutical and Biotech Industries
10 – 11 April • San Francisco, California USA
Supply Management Summit
14 – 15 May • Indianapolis, Indiana USA
Sponsorship and Table Top Exhibit
Opportunities Available
PINNACLE PROGRAMME 2013 GLOBAL SPONSORS
2
January/February 2013
PHARMACEUTICAL ENGINEERING
www.ISPE.org