Clinica 2025

Day	Session	Objective
Day 1	Morning	Animal Housing and Handling 1. Animal Daily Health monitoring 2. Acclimation Period and procedures 3. Animal Handling (Feeding and Cage Maintenance) 4. Animal House Visit
Day 1	Afternoon	Toxicity, Safety efficacy and Disease model Studies 1. Guidelines (OECD, GLP) 2. Grouping Techniques (Randomization, tagging), Dosage Fixation/ Dosage administration (Oral, IP, IV, and topical routes) 3. Toxicity study (Acute, Sub acute, Chronic) 4. Safety and Efficacy Study (NOAEL, LOAEL) 5. Disease Model Study
Day 2	Morning	Histopathology Sample collection 1. Dissection Techniques (Humane euthanasia, organ dissection) 2. Blood Sample Processing (Blood collection & Plasma/serum separation and storage) 3. Organ sample collection
Day 2	Afternoon	Histopathology Sample Processing 1. Tissue fixation, embedding 2. Microtome tissue Sectioning, staining 3. Tissue slide observation
Day 3	Morning	Biomarkers and Gene markers Evaluation 1. Biomarkers analysis 2. DNA extraction, PCR or ELISA overview and interpretation
Day 3	Afternoon	Statistical Data Analysis 1. Interpreting hematology, histopathology, and biochemistry data 2. GLP documentation, report formatting, result discussions 3. Procedures for Ethical Certificate

Day

Session

Objective

Day 1

Morning

Animal Housing and Handling 1. Animal Daily Health monitoring
2. Acclimation Period and procedures
3. Animal Handling (Feeding and Cage Maintenance)
4. Animal House Visit

Day 1

Afternoon

Toxicity, Safety efficacy and Disease model Studies 1. Guidelines (OECD, GLP)
2. Grouping Techniques (Randomization, tagging), Dosage Fixation/ Dosage administration (Oral, IP, IV, and topical routes)
3. Toxicity study (Acute, Sub acute, Chronic)
4. Safety and Efficacy Study (NOAEL, LOAEL)
5. Disease Model Study

Day 2

Morning

Histopathology Sample collection 1. Dissection Techniques (Humane euthanasia, organ dissection)
2. Blood Sample Processing (Blood collection & Plasma/serum separation and storage)
3. Organ sample collection

Day 2

Afternoon

Histopathology Sample Processing 1. Tissue fixation, embedding
2. Microtome tissue Sectioning, staining
3. Tissue slide observation

Day 3

Morning

Biomarkers and Gene markers Evaluation 1. Biomarkers analysis
2. DNA extraction, PCR or ELISA overview and interpretation

Day 3

Afternoon

Statistical Data Analysis 1. Interpreting hematology, histopathology, and biochemistry data
2. GLP documentation, report formatting, result discussions
3. Procedures for Ethical Certificate

27-06-2025	Core Topics
09:00 – 09:30 AM	Welcome and Orientation
09:30 – 10:30 AM	Introduction to Preclinical Toxicology Role of toxicology in the drug development pipeline Key terms: NOAEL, MTD, LD50, safety margins
10:30 – 11:00 AM	Break
11:00 – 12:30 PM	Designing a Toxicity Study Choosing the right species and dose Common routes of administration Study duration and regulatory expectations
12:30 – 01:30 PM	Lunch
01:30 – 03:00 PM	Toxicity Study Types and Their Purposes Acute, sub-chronic, and chronic toxicity studies Basics of genotoxicity, reproductive, and developmental toxicity
03:00 – 03:30 PM	Break
03:30 – 05:00 PM	Interactive Session: Design Your Own Study Groups design a preclinical study for a new drug candidate Present and discuss with peers

28-06-2025	Core Topics
09:00 – 10:30 AM	Histopathology in Preclinical Toxicology Why histopathology is critical in safety assessment Tissue collection, fixation and processing Reading histopathology reports: key findings in liver, kidney, and other organs Common lesions and their toxicological relevance
10:30 – 11:00 AM	Break
11:00 – 12:30 PM	GLP and Quality Assurance in Toxicology Studies What GLP means and why it matters Data integrity, documentation, and audits
12:30 – 01:30 PM	Lunch
01:30 – 03:00 PM	Interpreting Preclinical Data: Putting It All Together What regulators look for NOAEL determination Red flags and how to contextualize findings
03:00 – 03:30 PM	Break
03:30 – 04:30 PM	From Animal Studies to Regulatory Submission Role of toxicology in IND/IMPD Brief overview of Module 4 (nonclinical) in CTD Regulatory expectations for histopathology data
04:30 – 05:00 PM	Wrap-Up: Career Pathways and Feedback Careers in toxicologic pathology, CROs, regulatory agencies Certificate distribution and workshop feedback

The First Touch of
Tomorrow's Care

Core Benefits

Learn industrial guidelines

real time demonstration

Expert
Guidance

industrial certification

Latest technology in
cyber security

Powerful artificial
intelligence Multi-
Cloud security

core topics & Program Schedule

core topics & programme Schedule

in association with

The First Touch ofTomorrow's Care

Clinica 2025

Core Benefits

Learn industrial guidelines

real time demonstration

Expert Guidance

industrial certification

Latest technology in cyber security

Powerful artificial intelligence Multi- Cloud security

core topics & Program Schedule

core topics & programme Schedule

in association with

The First Touch of
Tomorrow's Care

Expert
Guidance

Latest technology in
cyber security

Powerful artificial
intelligence Multi-
Cloud security