1. CONCLUSIONS OF DEBATES
OUTLOOK FOR 2012
Vera ROGIERS
Dept. of Toxicology, Dermato- Cosmetology and Pharmacognosy Vrije Universiteit Brussel, Belgium

2. CONTENTS  SUMMARY OF POINTS OF INTEREST
 OUTLOOK FOR 2012 AND BEYOND: PERSONAL VIEW

3. CONTENTS  SUMMARY OF POINTS OF INTEREST
 OUTLOOK FOR 2012 AND BEYOND: PERSONAL VIEW

4. EVEIT : EX VIVO EYE IRRITATION TEST
POINTS OF INTEREST
EVEIT : EX VIVO EYE IRRITATION TEST
EPAA 2010 SCIENCE AWARD
REPLACEMENT EYE IRRITATION TEST : TAKEN UP BY INDUSTRY; INTEREST RAISED OF REGULATORY BODIES
TASK FOR EPAA FOLLOW-UP :
APPLICABILITY DOMAIN
LIMITATIONS
PREVALIDATION

5. VACCINES : POINTS OF INTEREST
RECOMMENDATIONS MADE BY START-UP (FP7 PROJECT) TAKEN UP BY EPAA
VACCINE CONSISTENCY APPROACH :
QUALITY CONTROL WITHOUT ANIMAL USE
OPPORTUNITY FOR EACH OF THE 3R’S
TASK OF EPAA : EXCELLENT DISCUSSION PLATFORM FOR ALL
PARTIES INVOLVED (ACADEMIC, INDUSTRY, REGULATORS,
ANIMAL PROTECTION) AT EU AND INTERNATIONAL LEVEL

6. epaa “MARKET PLACE” DEMAND SUPPLY TOOLS FOR INNOVATION
POINTS OF INTEREST
TOOLS FOR INNOVATION
epaa “MARKET PLACE”
DEMAND
SUPPLY
DIALOGUE IN BROADEST SENSE (REGULATORS)
RESEARCH: BASIC & TRANSLATIONAL
INFORMATION STREAM FROM AND TO ALL PARTIES

7. TOOLS FOR INNOVATION POINTS OF INTEREST
INCORPORATION OF “OMICS” TECHNOLOGY
INNOVATION IN CELL CULTURE
3D TECHNOLOGY
SCAFFOLD TECHNOLOGY
HUMAN CELLS: STEM CELLS/PROGENITORS
MINIATURISATION
HIGH CONTENT ANALYSIS
MONITORING IN SITU, USE OF SENSORS
SYSTEMS BIOLOGY, PATHWAY ANALYSIS
EPIGENETICS
IMPLEMENTATION OF NOVEL STRATEGIES IN RISK ASSESSMENT
INCORPORATION OF NEW CONCEPTS : QSAR, PBPK, BIOMARKERS, TTC, QRA, WoE,...

8. ITS : INTEGRATED TESTING STRATEGY
POINTS OF INTEREST
ITS : INTEGRATED TESTING STRATEGY
INTEGRATION OF IN SILICO, IN VITRO AND IN VIVO METHODS
PHARMACEUTICAL INDUSTRY IS POSITIVE, USED IN WoE APPROACH
IMPLEMENTATION IN ACTUAL EU LEGISLATION SEEMS POSSIBLE (ECHA, EFSA, EMA, ...)
NEED FOR WELL-DEFINED REGULATORY ACCEPTANCE PROCESS
NEED FOR QUALITY CRITERIA FOR ITS GENERATED DATA
ITS IS KEY PLAYER
IN PARADIGM SHIFT
FROM PATHOLOGY-BASED TOXICOLOGY
TO PATHWAY-BASED RISK ASSESSMENT

9. ITS : INTEGRATED TESTING STRATEGY
POINTS OF INTEREST
ITS : INTEGRATED TESTING STRATEGY
TO BE ACCEPTED IN REGULATORY COMPLIANCE PROCEDURE :
QUALITY CRITERIA
BASED ON VALIDATED OR VALID METHODS ?
Scientific validity
Robustness of methods/endpoints
Standardisation of assays/cell preparation
Reproducibility of results
Endpoints relevant for human risk assessment
Risk assessment decisions in case of failure of an individual test
Applicability domain
Transparent and consistent approach

10. RECOMMENDATIONS FOR WAY FORWARD ? INTERNATIONAL COOPERATION WITHIN :
POINTS OF INTEREST
ITS : INTEGRATED TESTING STRATEGY
RECOMMENDATIONS FOR WAY FORWARD ?
ROLE FOR EPAA :
INTERNATIONAL COOPERATION WITHIN :
INDUSTRY, ACADEMIA, DIFFERENT EU AND US REGULATORY AGENCIES, ECVAM, OECD, ...

11. DIRECTIVE 2010/63/EU (updated 86/609/EEC)
POINTS OF INTEREST
ITS : INTEGRATED TESTING STRATEGY
INTERNATIONAL ACCEPTANCE
ACTUAL EU LEGISLATIVE CONTEXT : VERTICAL LEGISLATION
C H E M I C A L S P R E A T I O N S P L A N T R O
T E C I
B I O C I D E S F O D A I T V E S M E D I C N A L P R O M E D I C A L V S D E T R G N S
C O S M E T I C S
DIRECTIVE 2010/63/EU (updated 86/609/EEC)
Adapted from Pauwels et Rogiers 2007, Regul Toxicol Pharmacol 49(3),

12. FIRST HARMONISATION WITHIN THE EU ?
POINTS OF INTEREST
ITS : INTEGRATED TESTING STRATEGY
IN EU: COMPLEX SITUATION
COSMETICS :
TESTING AND MARKETING BAN
1R → REPLACEMENT
“VALIDATED” ALTERNATIVES
REACH :
3Rs
“SUITABLE” ALTERNATIVES
PHARM :
ALL POSSIBILITIES ARE OPEN
ICH (SLOWLY) INCORPORATING 3Rs
“VALID” ALTERNATIVES
FIRST HARMONISATION WITHIN THE EU ?

13. CONTENTS  SUMMARY OF POINTS OF INTEREST
 OUTLOOK FOR 2012 AND BEYOND: PERSONAL VIEW

14. OUTLOOK FOR 2012 AND BEYOND : PERSONAL VIEW
Lacking European Parlement in MG meetings 4
START IN 2005
COMMISSIONERS
COMMISSION
MEMBERS
CO-CHAIR
INDUSTRY 2
Lacking Director for nearly
1 year 3
Senior decision level ?
NEED FOR REFLECTION BY PARTNERS
NEED FOR EPAA INTERNAL DISCUSSION
ALERT !!
EPAA WITH PUBLIC PRIVATE PARTNERSHIP IS EXCELLENT TOOL FOR INTERNATIONAL DISCUSSION AND PROGRESS IN BETTER SCIENCE
Not present in person in
2011 1
A SOLID HOUSE (EPAA) WITH STRONG FOUNDATIONS
(CO-CHAIRS OF HIERARCHIC LEVEL),
A SHELTERING ROOF (TOP COMMISSIONERS),
ACTIVE BUILDERS (MEMBERS OF DGs & INDUSTRIES)
AND A NICE SURROUNDING (HIGH EP REPRESENTATION)