Issuu on Google+

Toll free: 1800 425 9409  

Follow us on social network

India Seminar 2012 at Mumbai RAPS Approved Seminar on

GMP and Regulatory Expectations for Early IND Products RAPS Approved. Earn 12 RAC Points Course "GMP and Regulatory Expectations for Early IND Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview

Dr. Steven S. Kuwahara

Any pharmaceutical worker who must deal with products both in early and latter phases of development should attend this course in order to be aware of the regulatory requirements that will affect operations dealing with these products. The course will present these items in the order of product development from the point of R & D activities to the completion of Phase 2 clinical trials.

Download Brochure Date and Venue

Founder & Principal, GXP Biotechnology, LLC Dr. Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . more...

June 18th, 19th and 20th, 2012 Venue: Intercontinental The LaLit, Sahar Airport Road, Andheri East Mumbai - 400059 INDIA

Download Registration Form For Sponsorship

Agenda

Conference timings: 9:00 am - 6:00 pm

Day 1 - 18th June 2012

Day 2 - 19th June 2012

Day 3 - 20th June 2012

Lecture 1: Very Early Stages:

Lecture 5: Early Pre-IND Studies:

Lecture 9: GMPs for Phase 1 Products. Part 1:

l

The effects of ICH Q8 l Impact on R & D activities

Lecture 2: What the ICH Q8 Annex covers: Early pharmaceutical development activities l Elements of pharmaceutical development l

Lecture 3:GLP requirements: Non-clinical studies and the GLP requirements l The Animal Welfare Act l

Lecture 4 GLP-based Animal Studies: l l

Animal pharmacology studies So called GLP testing.

ICH S5 Guidance on preparing for clinical studies l Preclinical safety evaluations l Exploratory studies

Regulatory issues Regulations and the Food Drug and Cosmetic Act l General guidance l Specific GMP requirements for Phase 1 products

l

l l

Lecture 6: The Preclinical/Clinical Interface:

Lecture 10:GMPs for Phase 1 More on exploratory studies Determination of the maximum safe Products. Part 2: starting dose for humans l Specific GMP requirements. Continued Lecture 7: The Animal Rule and l Special manufacturing situations Orphan Drugs: l Multi-product facilities l Biologic and biotechnology l Safety studies products l Relating animal effects to human l Biosimilars effects l Orphan drugs l Establishing an orphan status Lecture 11: Phase 2 Products: l Exclusivity l Considerations due to orphan l Making the transition to full GMP status l Considerations for Phase 2 products l l

Lecture 8: Pediatric considerations: l

Lecture 12: Early IND Meetings:

The pediatric rule and reasoning for

it l

l

Pediatric exclusivity

l

Importance of early meetings Guidance on Meetings l Requesting a meeting l Content and format of the meeting

 

    Contact Information: Event-coordinator Phone number: +91 080-3247-3694 / +91 80-3201-4957 Fax number: +91 80-2642-1483 Email:

customersupport@globalcompliancepanel.com GlobalCompliancePanel

Pricing List Register By

Price INR

Savings

Between March 26th to May 26th

16,000

2,000

Between May 27th to June 17th

18,000

0

 


C/O NetZealous Services India Pvt. Ltd. 4th Floor, A, Block, Brigade Software Park, Banashankari 2nd stage, Bangalore-560070. INDIA

  We will be able to accommodate limited number of attendees so if you and your colleagues would like to attend this training seminar, call us today at +91 80-3221-3341 / +91 80-3247-3696 / +91 80-3221-3329 to reserve your seat. Download the Registration Form Best regards, Team GlobalCompliancePanel

If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

 

This message was sent to you by: GlobalCompliancePanel www.globalcompliancepanel.com  

 

 


RAPS Approved Seminar on GMP and Regulatory Expectations for Early IND Products At Mumbai