KNOWLEDGE MANAGEMENT
From Discovery to Patient
Enabling Knowledge Flow,
Delivering Safe &
Effective Products
26th and 27th March 2015
Dublin Castle, Ireland
DAY
ONE
TIME
SESSION
SPEAKER
9.00 -
9.10
OPENING
Nuala Calnan
REMARKS
9.10 - WELCOME
Pat O’ Mahony
9.40
ADDRESS
SPEAKER TITLE/ ROLE
SESSION TITLE & OVERVIEW
KM Dublin 2015, Chair Opening of KM Dublin 2015 and
Outline of Symposium Events
Chief Executive, Health Products Regulatory Authority (HPRA)
Regulatory Science Ireland:
Ireland’s response to the global
Regulatory Science effort
9.40 -
KEYNOTE
Ed Hoffman
Chief Knowledge Officer, 10.25
SESSION
NASA
10.25 -
Jacques Morenas
10.55
KEYNOTE
SESSION
10.55 - 11.15
Integrating Knowledge Management and Risk Management: Lessons from NASA
Deputy Director of Inspections, Knowledge as an Enabler for the
French Health Products Safety Pharmaceutical Quality System
Agency (ANSM)
COFFEE
11.15-
11.45
KEYNOTE
Stephan Rönninger Head, External Affairs Europe, Achieving Basic Understanding &
SESSIONS
International Quality, Amgen
Practical Implementation of
11.45 -
12.15
KEYNOTE
Barbara Allen
SESSION
12.15 - 13.00
HAVE
Breakout session 1: Choice of Four Break Out
YOUR SAY
Tracks to select from
13.00 - 14.00
14.00 -
14.30
Integrating Knowledge Management
with Quality Management Systems
LUNCH
Moderated Feedback
MODERATED
Mike Morris
Director of Scientific Affairs,
FEEDBACK
HPRA
from Breakout Session 1
from Breakout
Session 1
14.30 -
KEYNOTE
Yukio Hiyama
15.00
SESSION
15.00 -
15.55
Senior Director for Global Quality Systems, Eli Lilly
Knowledge Management
Visiting Scientist (retired) at National Institute of Health Sciences (NIHS), MHLW, Japan INTERACTIVE
Beyond ICH Q10: Enhanced Risk Management
PANEL
through Knowledge Management
DISCUSSION
15.55 - 16.15
Challenges in Knowledge Sharing
Moderated Panel & Audience
Discussion
Coffee 16.15 -
RESEARCH
Nuala Calnan Regulatory Science 16.45
SESSION
Researcher, DIT
KM - The Orphan Enabler: Protecting
the Patient through Effective Use of
Knowledge.
16.45 -
INDUSTRY
Mark Wolff
Principal Industry Consultant, 17.15
INSIGHTS
Health & Life Sciences Global Practice, SAS Institute Enhancing Post-Marketing
Surveillance: An Analysis of Self-Reported Health Outcomes and
Safety Data from Web-Based Media
Sources’ for FDA/CDRH
17-15 -
CLOSING
Michael Thien
18.00
ADDRESS
Senior Vice President, Global Creating a successfull KM capability
Science, Technology and
- A leaders responsibility
Commercialization, MSD/Merck
18.00 - 18.15
Minister for Health, Irish Government
CLOSING
Leo Varadkar
REMARKS
18.30-20.00
Evening Reception Throne Room &
Portrait Gallery
An address by the Minister
for Health
Dublin Castle
All Welcome
DAY
TWO
TIME
SESSION
SPEAKER
SPEAKER TITLE/ ROLE
8.30 - 8.45
OPENING
Nuala Calnan
KM Dublin 2015, Chair REMARKS
8.45 -
9.30
OPENING
Cindy Hubert
ADDRESS
American Productivity & Quallity Centre (APQC)
9.30 -
10.00
INDUSTRY
Marty Lipa
INSIGHTS
Executive Director Knowledge A Practical Approach to Managing
Management, MSD / Merck Knowledge – a Case Study in Merck
10.00 -
10.45
HAVE
Breakout session 2:
YOUR SAY
10.50 - 11.30
12.30 -
Daphne Smyth
13.00
Sr Dir Regulatory Affairs, ICON Clinical Research
HAVE
Breakout session 3:
YOUR SAY
Choice of Four Break Out Tracks
to select from
Pfizer’s Journey to knowledge
utilization and leveraging KM for
Product and Process Understanding
Management of Knowledge from a
CRO perspective
MODERATED
Anne Greene
FEEDBACK
from Breakout
Session 2
Choice of Four Break Out Tracks
to select from
Principal Reviewer, Office of
Cellular and Tissue-based
Products, PMDA, Japan
Sr. Director, Pfizer Global
Quality Intelligence and
Compendial Affairs, UK
Senior Biological Assessor in
the Licensing Devision,
Danish Health and Medicines
Authorities (DHMA), Denmark
Moderated Panel & Audience
Discussion on outcomes from the
KM sessions with ICH Q12 Team
Members
Head of Pharmaceutical Regulatory Science Team & Pharmaceutical Projects
Manager, DIT
Moderated Feedback
from Breakout Session 3
Hansjürg Leuenberger OMCL (Laboratory)
& Michael Renaudin at Swissmedic Regulatory
Authority
15.50 -
16.30
Manufacturing
LUNCH
14.45 -
INTERACTIVE
Yasuhiro Kishioka
15.30
PANEL
DISCUSSION
Graham Cook
Nanna Aaby Kruse
15.30 -
15.50
The New Edge in Knowledge:
Enabling flow
Moderated Feedback
Unit Manager Inspectorate
Risk, Control & Governance, from Breakout Session 2
Medicines and Healthcare
products Regulatory Agency
(MHRA), UK
12.00 -
INDUSTRY
Paige Kane
Director of Knowledge 12.30
INSIGHTS
Management, Pfizer 12.50 - 2.00 Lunch
14.00 -
14.45
A brief review of Day 1 and an outline
of Day 2 events
COFFEE BREAK & THE KNOWLEDGE CAFÉ
11.30 -
MODERATED
Ian Jackson
12.00
FEEDBACK
from Breakout
Session 2
12.50 - 14.00
SESSION TITLE & OVERVIEW
REGULATORY
INSIGHTS
Applying Knowledge at SwissMedic
16.30 -
CLOSING
Emer Cooke
Head of International Affairs,
17.00
ADDRESS
European Medicines Agency The Future of Regulatory Science
(EMA)
www.kmdublin2015.ie
TRACK 1
TRACK 2
TRACK 3 TRACK 4
PAIGE KANE
MARTY LIPA
JOSE C. MENEZES
NUALA CALNAN
TRACK TITLE
/ THEME
Building a Culture of
Knowledge Sharing
(PEOPLE)
Achieving Knowledge
Flow
(PROCESS)
Managing Knowledge in the Digital Age
(TECH)
MedTech/ CRO /CMO’s
SESSION 1
(Thurs pm)
What is Knowledge? Towards a Taxonomy
Facilitator: Paige Kane
Co-facilitator: Imelda O’Connor (Pfizer)
What is Knowledge?
Towards a Taxonomy
Facilitator: Marty Lipa
Co-facilitator:
Dermot O’Brien (Merck)
What is Knowledge? Towards a Taxonomy
Facilitator: Jose Menezes
Co-facilitator:
Amr Arisha (DIT)
What is Knowledge?
Towards a Taxonomy
Facilitator:Nuala Calnan
Co-facilitator:
Ursula Busse (Novartis)
Mining Insights from the Web? Dealing with issues of
veracity when mining web based knowledge
Facilitator: Mark Wolff
(SAS Institute)
Co-facilitator:
Paul Acton (SAS Institute)
Managing Knowledge
Challenges in MedTech
Facilitator:
Cormac Dalton (AbbVie)
Co-facilitator:
Nuala Calnan (DIT)
SESSION 2
(Fri am)
Approaches to steward Process and Product
organizational knowledge Knowledge - Identification
sharing
and retention strategies
Facilitator: Facilitator: Brian Flynn (Genzyme)
Jean Wyvratt (ex Merck)
Co-facilitator:
Co-facilitator:
Kate Coleman (Sanofi)
Anne Greene (DIT)
SESSION 3
(Fri pm)
Leveraging the tacit How do you overcome Leveraging your Current
knowledge in your
challenges in Knowledge Technology Tools to Drive
organisation
Flow?
more Effective KM
Facilitator:Facilitator:Facilitator:
Noel Cronin (Amgen)
Cindy Hubert (APQC)
Alice Redmond (CAI)
Co-facilitator:
Co-facilitator:
Co-facilitator:
Ken Ryan (Pfizer)
Kelly Waldron (Genzyme)
Tim Howard (CAI)
(OTHER)
Using your knowledge
to improve future project
outcomes
Facilitator:
Pam Howard (ICON)
Co-facilitator:
Susan Neenan (Alexion)