Agenda

Day 1 Feb 24, 2014

8:00 AM — 8:30 AM

REGISTRATION

8:30 AM — 8:45 AM

COURSE INTRODUCTION AND OVERVIEW

8:45 AM — 9:45 AM

THE DRUG DEVELOPMENT PROCESS AND REGULATORY ASPECTS

9:45 AM — 10:45 AM

PROCEDURES AND GUIDELINES

10:45 AM — 11:15 AM

COFFEE BREAK

11:15 AM — 12:00 PM

WHAT IS ICH? ICH SAFETY GUIDELINES

12:00 PM — 1:00 PM

COMMON TECHNICAL DOCUMENT AND LABELLING

1:00 PM — 2:00 PM

LUNCH

2:00 PM — 3:00 PM

PHARMACOKINETICS AND METABOLISM (TOXICOKINETICS)

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 4:30 PM

SPECIES SELECTION IN DRUG DEVELOPMENT. ALTERNATIVES TO ANIMAL STUDIES - THE 3RS

4:30 PM — 5:30 PM

SAFETY PHARMACOLOGY

5:30 PM — 5:45 PM

INTEGRATING KINETICS AND METABOLISM CASE STUDIES WITH ROUND TABLE DISCUSSION

5:45 PM — 6:45 PM

DRINKS RECEPTION

Day 2 Feb 25, 2014

9:00 AM — 10:00 AM

REPEATED DOSE TOXICITY

10:00 AM — 11:00 AM

REPRODUCTIVE TOXICITY

11:00 AM — 11:30 AM

COFFEE BREAK

11:30 AM — 12:30 PM

SPECIAL ORGAN TOXICITY: LIVER

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

GENOTOXICITY

2:30 PM — 3:00 PM

COFFEE BREAK

3:00 PM — 5:00 PM

GROUP ACTIVITY

7:00 PM — 10:30 PM

WORKING DINNER

Day 3 Feb 26, 2014

9:00 AM — 10:00 AM

NON-CLINICAL DEVELOPMENT OF ANTI-CANCER DRUGS

10:00 AM — 11:00 AM

ENVIRONMENTAL RISK ASSESSMENT OF MEDICINAL PRODUCTS FOR HUMAN USE

11:00 AM — 11:30 AM

COFFEE BREAK

11:30 AM — 12:30 PM

M3 GUIDELINES - PRECLINICAL STUDIES TO SUPPORT FIRST HUMAN CLINICAL TRIALS

12:30 PM — 1:30 PM

LUNCH

1:30 PM — 2:30 PM

INTRODUCTION TO PRINCIPLES AND FIRST IN HUMAN WITH CASE STUDY

2:30 PM — 3:30 PM

INTEGRATING RISK ASSESSMENT WITH CASE STUDY

3:30 PM — 4:00 PM

COFFEE BREAK

4:00 PM — 5:00 PM

TOXICOLOGICAL QUALIFICATION OF IMPURITIES

Day 4 Feb 27, 2014

8:30 AM — 9:30 AM

PRECLINICAL CONSIDERATIONS FOR BIOTETCHNOLOGY PRODUCTS

9:30 AM — 10:30 AM

PRECLINICAL CONSIDERATIONS FOR BIOSIMILARS

10:30 AM — 11:00 AM

COFFEE BREAK

11:00 AM — 12:30 PM

ESTIMATION OF FIRST IN HUMAN DOSE: CASE STUDY FOR GROUP ACTIVITY

12:30 PM — 2:00 PM

LUNCH

2:00 PM — 3:00 PM

PRECLINICAL STUDIES FOR PEDIATRIC INDICATIONS_JUVENILE ANIMAL STUDIES

3:00 PM — 3:30 PM

COFFEE BREAK

3:30 PM — 5:00 PM

STRATEGIES FOR CARCINOGENICITY TESTING OF HUMAN PHARMACEUTICALS

5:00 PM — 6:00 PM

INTEGRATING RISK ASSESSMENT WITH CARCINOGENICITY LIVER TUMOR CASE STUDY

Day 5 Feb 28, 2014

8:30 AM — 9:15 AM

SPECIAL ORGAN TOXICITY – PART TWO: IMMUNE SYSTEM TOXICITY

9:15 AM — 10:00 AM

NON-CLINICAL TESTING OF VACCINES AND ADJUVANTS

10:00 AM — 10:30 AM

COFFEE BREAK

10:30 AM — 1:30 PM

EXAMINATION

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Non-Clinical Safety Sciences and Their Regulatory Aspects

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