BIOCRAFT SCHOOL OF PRECLINICALS Pvt.Ltd.

Shaping Your Future.

WORKSHOP ON PRECLINICAL RESEARCH

SCHEDULED ON 5th , 6th & 7th of July 2012

SCHEDULE

TIME
9.00 AM to 10.00 AM

DAY 1
Inauguration and welcome, Introduction of participants Introduction to Bioneeds Overview of the BIOCRAFT Technical Session: 1 hr

DAY 2
Technical Session: 1 hr Toxicity Studies

DAY 3
Technical Session :1 hr Regulatory Affairs GLP/GCP/GMP

Technical Session:1hr Eco-Toxicology

Technical Session: 1 hr Animal Models ,PK/PD studies

10.00 AM to 11.00 AM 11.00 AM to 11.15 AM

Animal House: Design, Equipment & Environment.

Tea Break
Technical Session: 1 hr 15 m

Tea Break
Technical Session: 1hr 15 m Inhalation-Toxicology

Tea Break
Technical Session: 1 hr Safety pharmacology

11.15 AM to 12.30 PM

Care and Management of Laboratory Animals

12.30 PM to 1.15 PM

Lunch
Practical Session : 1 hr 45m

Lunch
Technical + Practical Session: 1 hr 45 m Geno-Toxicity Practical Session: 1 hr Toxicity Studies Invivo procedures

Lunch
Practical session: 1 hr 45 m Polyclonal Antibody Production in Rabbits and Guinea Pigs Practical Session: 1 hr Necropsy , Cannulation

1.15 PM to 3.00 PM

Animal House: Design, Equipment & Environment Practical Session : 1 hr

3.00 PM to 4.00 PM

Care and Management of Laboratory Animals

4.00 PM to 4.15 PM

Tea Break
Practical Session: 2 hr

Tea Break
Valedictory, Practical Session : 2 hr

Tea Break

4.15 PM to 6.00 PM

Care and Management of Laboratory Animals

Certificate Issue Toxicity Studies Lab procedures

DAY 1st WELCOME :

Inaguration and welcome Introduction of participants Overview of the workshop Introduction to Biocraft & Bioneeds

Entrance

Inauguration

Presentation

Training hall

Lab area

Practical session

Practical Session

Practical session

Animal facility

Discussion

Valedictory

Issuing certificates

DAY 1: TIME: 10.00 am-11.00 am ( 1 hr): Theoratical

Session

Day -1 : SCHEDULE

ANIMAL HOUSE: DESIGN, EQUIPMENTS & ENVIRONMENT Design, Equipments: Ex: Autoclave, balances, fumigator, AHU etc Environment: Climate, space, light, sound, temperature, humidity, daily rhythms, Hygiene in animal house, Safety in animal house. Sterile and disinfection methods.

DAY 1: TIME: 11.15am - 12.30pm (1 hr 15 m): Theoratical Session

CARE & MANAGEMENT OF LABORATORY ANIMALS Introduction to laboratory animals. National and international regulation and policies. Institutional regulations and policies. Use of laboratory animals., Housing systems. Environment: temperature, humidity, ventilation, light effects. Husbandry : food, water, bedding, sanitation, Nutrition, Breeding Systems, Reproduction Veterinary care, Common diseases, diagnosis and control, Health monitoring, Genetic monitoring Biowaste management, Pest control, Lab animal resources in India and abroad. Records to be maintained in the animal house, Occupational health hazards. DAY 1: TIME: 1.15pm 3.00pm (2 hr): Practical Session Entry / exit procedures to animal house Work flow demonstration material and personnel Dual corridor system: clean and service corridor system Safety precautions and provisions, Air circulation & pressure gradients Quarantine room and release procedure, Sterilization/ autoclaving process Feed receipt, storage, sterilization, and issue process Housing system Rat, Mice, Rabbits, Guinea Pigs and dogs Collection of urine, feces metabolic cages, Feeds Different types, Nesting materials DAY 1: TIME: 3.00 pm to 6.00 pm (3 hrs): Practical Session Personnel safety while handling animals, Identification of body parts rats, rabbits Handling: rats, mice, hamsters, guinea pigs, rabbits & dogs. Restraining of rats, mice, hamsters, guinea pigs, rabbits & dogs Administration: Oral, SC, IV, IM, Nasal, IP, Intradermal. Blood Collection: Retro orbital, tail vein, jugular vein, cardiac puncture, saphenous vein, ear vein in rabbits, carotid artery in rabbits Animal identification methods, Anesthesia procedure, Euthanesia procedure, Breeding system Sexing methods, Weighing procedure, Litter standardization

Day -2 : SCHEDULE
DAY 2: TIME: 9.00 am-12.30 pm : LECTURE
TOXICITY STUDIES Introduction to toxicological evaluation of food, drug, pesticides, cosmatics, herbals, neutraceuticals, biosimilars biopharmaceuticals and ayurvedic drugs. National & International guidelines governing the toxicity studies. GLP and toxicity studies. General toxicity studies. Chronic & carcinogenetic studies. Teratology studies / Reproductive toxicity studies seg I - III Genetic Toxicity studies. Ecotoxicity studies. Inhalation Toxicity studies. Dermal Toxicity studies. Ocular studies. Immunotoxicity studies. Local toxicity studies.

DAY 2: TIME: 1.15 pm to 6.00 pm : DEMO

Preparation of animal room for the study fumigation Acclimatization Body weight measurement and stratification /grouping Observation procedure for toxicity symptoms Recording of the raw data and documentation Balance usage and calibration Neurological examination Hematology analysis Biochemistry analysis Urine analysis Histopathology: Tissue Processing, blocking, slide preparation, staining and slide evaluation

Day -3 : SCHEDULE
DAY 3: TIME: 9.00 am-10.00 Am (1 hr): LECTURE SAFETY ASSESMENT / PHARMACOLOGY Introduction to safety pharmacology studies Regulatory guidelines for safety assessment, Principles of safety pharmacology Safety studies Central nervous system, Cardiovascular system, Respiratory system Gastrointestinal system, Renal/urinary system, Autonomic nervous system Challenges and future of safety pharmacology DAY 3: TIME: 10.00 am-11.00 am (1 hr): LECTURE ANIMAL MODELS, PK/PD STUDIES Cardiovascular disease models, Urinary tract disease models Respiratory system models, Neuro- behavior models Neuro-muscular models, Anti-inflammatory models Antipyretic models, Immunological models Gastrointestinal models, Metabolic disease model- Anti diabetic , Anti obesity Ophthalmological models, Dermatological models DAY 3: TIME: 11.15 am-12.30 pm : LECTURE Regulatory Affair. Introduction to GLP, Facility and resources, Quality Assurance Unit, Standard Operating Procedures Test item, Test system, Performance of the study, Archiving DAY 3: TIME: 1.15 pm-3.00 pm : DEMO Polyclonal Antibody Production Antigen storage, Adjuvants used, Administration, Blood collection &separation, Serum storage

DAY 3: TIME: 3.00 pm - 4.00 pm (1 hrs): DEMO

Necropsy of rats, gross necropsy, organ collection, preservation of organs. Jugular vein cannulation, Dermal application of test item - guinea pigs and rabbits. DAY 3: TIME: 4.15pm-6.00 pm -Valedictory , -Certificate issue.

View of Bioneeds

Front view

Visitor lobby

Clean service corridor

Experimental rooms

Experimental rooms

Laboratories block

Histopathology lab

Clinical chemistry lab

Test item store

Microbiology lab

Conference Hall

REGISTRATION PROCESS :
BIOCRAFT SCHOOL OF PRECLINICALS
Sl No Training Charges for In-house programmes on the basis of number of days of Training as indicated below: Training Type Code Description Duration Course Fees in INR Discounts

For Corporates

a b a b a b C

Per Participant For 3 Day For group registrations more than 15 For 3 Day Per Participant For 3 Day For group registrations more than 15 For 3 Day Students For 3 Day For group registrations more than 15 For 3 Day If any additional demonstration beyond scope of the syllabus For 3 Day Registration fees Includes

15,000 15,000 12,500 12,500 10,000 10,000

Not Applicable Applicable Not Applicable Applicable Not Applicable Applicable

For Professionals ( Faculties / Research Scholars)

For Academic Institutions ( Students)

In-House package rates are for a batch of 15 persons

Payment Options available for Fee 1) Cash 2) Demand Draft 3) Online Fund Transfer 4) Cheque

Training Plan/Schedule Training Material/Technical Inserts Bag,Pen, Notepad, Tea ,Lunch Training Certificate

will be charged extra Applicable Mode of Payment Training fee is to be paid in the form of Demand Draft drawn in favour of "BIONEEDS"

Terms and Conditions :

If we found any misbehavior or misconduct from the participants during the workshop training, management has full rights to disqualify and discontinue those participants. Mobiles and Cameras are not allowed inside. Batch is limited to 20 registrations only. If group registrations from the academic institutions/ industries we offer special discounts. Syllabus can be customized based on the specialization, needs and academic book group of the participants for Institutions and Industries. To confirm your reservation and enroll for the course you must do so atleast 7 working days prior to course commencement by completing the registration form and 100% advance through DD or cheque payable at Allahabad bank,J.C.Road ,Tumkur. Any additional demonstration beyond scope of the syllabus can also be included with prior intimation from the participants.

Mr. Madhusudhan.H.S
Mobile : 07760970795

Mr. D.M. Shiva Reddy

Mobile : 09632544566 Telephone: 0816 -2243751-55 Email Address: biocraft@bioneeds.in Fax: 0816 - 2243333 Website: www.biocraftpreclinicals.com www.bioneeds.in

Office Address:

BIOCRAFT SCHOOL OF PRECLINICALS Pvt. Ltd.

Devarahosahally, Sompura hobli , Nelamangala Taluk Bangalore Rural 562 111 Karnataka, INDIA.

biocraft@bioneeds.in Biocraft Spw Biocraft School of Preclinical Pvt. Ltd.