ISPE Nordic
Annual Conference 2015
26 November - World Trade Center - Stockholm
Nor
Affi
Nordic
Affiliate
FUTURE ISSUES OF
PHARMACEUTICAL
PRODUCTION
Speakers at the Annual Conference
Thomas Eldered, CEO, Recipharm
Thomas Eldered has served as an executive officer of Recipharm since he founded the Company together
with Lars Backsell 1995. Prior to founding Recipharm Thomas served in various management positions in
Pharmacia AB. Thomas serves as Chairman of the board of Cobra Biologics Holding AB, a leading biologics
CMO, and also serves as Board member of Sweden Bio, Chromafora AB, a clean tech development company.
Anki Malmborg Hager, CEO, SenzaGen
Being an inventor herself of a technology that is the base for a biotech company, Anki has the full insight and
experience in starting up small businesses. Having worked for several small biotech companies, both as CEO
and board member, and as an investment director, she understands the challenges these businesses face.
She is the author about 30 scientific papers and book chapters, and the inventor on a number of patents.
Anders Sveno, Head of Regulatory Project Management, Meda AB
In 2012 started as Regulatory project Manager at Meda AB and later on moved in to the position as head of
department. Current role involve Regulatory strategies for new and established products. Deeply involved in
manufacturing transfer projects. This means significant interactions with the technical experts at the CMO’s,
including responsibility for validation and stability strategies.
Magnus Jahnsson, Director Regulatory Affairs, Pharmadule Morimatsu
Magnus has more than 20 years pharma experience, both from the industry and from regulatory authorities.
He has worked extensively in the fields of R&D, manufacturing, QA and regulatory affairs. Furthermore
Mr Jahnsson is also an appreciated speaker on GMP, Drug development and Regulatory subjects. He has
given numerous of lectures and courses for ISPE and other organizations.
Nuala Calnan, Regulatory Science Research Fellow, Dublin Institute of Technology
Nuala has over 20 years experience in the pharmaceutical industry including roles at Leo Pharma, Elan, Wyeth BioPharma (Pfizer), PM Group and is currently a member of the Pharmaceutical Science & Regulatory
Team at DIT, Ireland.
Rickard Fjaestad Gustafsson, Director Quality Systems , Astra Zeneca
Rickard holds broad experience from pharmaceutical development and manufacturing, having worked 22
years in the pharmaceutical industry. He has a proven track record of quality leadership with previous roles including being a Qualified Person in sterile manufacturing, process development, pre-clinical research, supplier
quality management and management roles in QA.
Anne Sofie Österdal, Process Expert Quality Metrics, NovoNordisk
Anne Sofie is currently a Process Expert within Quality Metrics and Applied Statistical Techniques. She has a long
experience for the pharma industry including areas such as lean/six sigma, quality risk management, QbD, risk
analysis and SAS programming.
World Trade Center, Stockholm, 26 November
CONFERENCE THEME - FUTURE ISSUES OF PHARMACEUTICAL PRODUCTION
08.00 - 09.00
CONFERENCE REGISTRATION AND COFFEE
09.00 - 09.15
Introduction & Announcements
09.15 - 10.00
Recipharm - From an Opportunity Driven Domestic Start-up to a Leading
CDMO with Global Aspirations
Anders Widov, Vice Chairman ISPE Nordic Affiliate
Thomas Eldered, Recipharm
10.00 - 10.45
SenzaGen - From Lab to Global Market
10.45 - 11.15
NETWORKING BREAK
11.15 - 12.00
Manufacturing Transfers of Established Drug Products –
A Challenge in the “New” Regulatory Environment
Anki Malmborg-Hager, SenzaGen
Anders Sveno, Meda AB
12.00 - 12.45
Risk Communication - an Industry Challenge
12.45 - 13.45
LUNCH
13.45 - 14.30
Measuring Performance - Driving Excellence
14.30 - 15.15
Quality Metrics - Gain or Pain?
Magnus Jahnsson, Pharmadule Morimatsu AB
Nuala Calnan, Dublin Institute of Technology
Rickard Fjaestad Gustafsson, AstraZeneca
15.15 - 15.45 NETWORKING BREAK
15.45 - 16.30
Measuring and Driving Quality at Novo Nordisk
16.30 - 16.45
Summary and Final Remarks
16.45 - 17.15
ISPE Nordic Annual General Meeting
17.15 - 17.45
GAMP Nordic Annual General Meeting
Anne Sofie Österdal, NovoNordisk
17.45 - 18.00 Refreshing before Dinner
18.00 - 22.00 Annual Dinner
Registration
Please register on:
https://ispenordic.nemtilmeld.dk/10/ before November 7.
Conference Fee* - Member of ISPE
Euro 400
Conference Fee* - Non-member **
Euro 580
Conference Fee* - Academia/Young Professional Member
Euro 150
Conference Fee* - Academia/Young Professional Non-Member
Euro 200
Conference Fee* - Student/Regulatory Member
Euro 75
Conference Fee* - Student/Regulatory Non-Member **
Euro 90
Dinner only
Euro 100
Table Top Exhibition***
Euro 600 +
conf. fee
Image Courtesy of Pharmadule.
* The conference fees include access to all sessions, lunch, breaks and the
dinner. Note that the fee will not be deducted if you are not participating the
dinner.
** Includes 1- year membership of ISPE with all membership benefits please visit www.ispe.org
*** Includes conference pass and dinner for one person
If you have any questions regarding the conference or registration, please contact:
Anders Widov, anders.widov@wiphe.se (+46 708 29 41 90)
Claes Danell The Power of Body Language
Claes has reached millions of people thru the TV show Phenomenon.
Claes have also taken part in a prestigious competition of magicians in
London as one of 16 invited participants from all over the world. Now
Claes travels around with his magical
show or lecture to amaze or inspire
people all over the world.
Everybody talks about the importance of body language , but few
people understand how much of an
effect it actually has not just on how
others perceive us , but it may also
change how we see ourselves and
have an impact on our chances of
success.
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