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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.


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

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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:


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

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


Pediatric exclusivity


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: GlobalCompliancePanel

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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

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