gmp and regulatory expectations
DESCRIPTION
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 modifications to the GMPs for early phase products have modified the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time some of the things that may appear to have changed, have not, and the pharmaceutical worker should be aware of this.TRANSCRIPT
USA Seminar 2012 at San Diego
GMP and Regulatory Expectations for Early IND Products
Dr Steven S. Kuwaharaby
On 5th and 6th April, 2012 at San Diego
About GlobalCompliancePanel:
GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high
quality regulatory and compliance-related services.
At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,
Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we
have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these
sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective
experience are associated with us.
Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT
Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group
viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as
J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.
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Net Zealous
Dr Steven S. Kuwahara Founder & Principal, GXP Biotechnology, LLC
USA Seminar 2012 at San Diego
About Speaker:Dr. Kuwahara currently heads GXP BioTechnology . He is an experienced analytical biochemist who has applied his
knowledge to the quality control area of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in
relation
to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and
nutritional supplements.
Dr. Kuwahara has written many papers and book chapters, and serves on the editorial advisory boards of BioPharm,
BioQuality, Journal of Validation Technology, and Journal of GXP Compliance. For the last of these, he also writes a
column called “The GLP Forum.”
He has held certifications such as CQA, CQT, and CQE from the American Society of Quality, and was certified RAC
by the Regulatory Affairs Professionals Society.
April 5th and 6th, 2012 at San Diego
Will be announced soon
Date and Venue:
Past Seminars
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Seminar Content: Conference timings: 9 AM PDT to 5 PM PDT
Day 1 - 5th April 2012 Day 2 - 6th April 2012
USA Seminar 2012 at San Diego
Lecture 1: Very Early Stages
„ The need for documentation of matters that will affect downstream work.
„ The effects of ICH Q8
– Impact on R & D activities
– Risk analysis and design control at this stage
Lecture 2: GLP requirements
„ Animal studies
– Toxicology and pharmacokinetics
„ Estimating the Maximum Safe Starting Dose
– A review of the guidance document
Lecture 3: Early Pre-IND Studies
„ Understanding exploratory Studies
– Definitions and the IND that will be withdrawn
„ Orphan Drugs
„ Drugs studied under the Animal Rule
– What they are and how to conduct the studies
Lecture 4: Meetings and Preparing for the IND
„ Information required for the Phase 1 IND
– The CMC requirements that will be needed.
„ Pre-IND Meetings with FDA
Lecture 5: GMPs for Phase 1 IND products
„ The scope of the guidance document
„ The second guidance document covering the GMPs
Lecture 6: GMPs for Phase 1 continued
„ A presentation covering what GMPs are required at this stage.
„ What has been omitted from the GMPs for Phase 1
Lecture 7: Requirements for Phase 2 INDs
„ The full GMPs resume, but do they?
„ Phase 2 studies and the transition to full GMPs.
„ CMC requirements
Lecture 8: Preparing for IND Meetings
„ Phase 1 meetings
„ Pre-phase 2 meetings
„Phase 2 meetings
Why should you attend:This course will present, in one place, the regulations and guidelines that apply to early phase products. In some cases these will
not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development
process. 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.
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How to Register:
v Register online. Use your American Express, Visa or MasterCard
v For group discount of more than 5 attendees call 800-447-9407
v Call +1 - 800-447-9407 or Fax your PO: 302-288-6884
v Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,
6552 Palisades Dr. Centreville, VA 20121
Contact Information:Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
GlobalCompliancePanel
NetZealous
1000 N West Street,
Suite 1200, Wilmington,
DE 19801..
Kindly get in touch with us for any help or information.
Look forward to meeting you at the seminar
Team GlobalCompliancePanel
USA Seminar 2012 at San Diego
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
notepad and pen.
9. Networking with industry's top notch professionals
Companies that will benefit:
† Small Molecule Drug Companies
† Biologic Companies
† API and Generics Manufacturers
Pricing List:
1. Price for One Delegate pass
$1895 (Between March 23th to April 25th)
-----------------------------------------
2. Early bird price for one Delegate pass $1695
(Between February 16th to March 22th)
-----------------------------------------
3. For discounts on multiple registrations, contact customer care at 1800 447 9407
Professionals who will benefit:
£ Directors
£ Managers
£ Supervisors, and lead workers in
Regulatory Affairs
£ Quality Assurance and Quality Control
£ Workers who will prepare GMP
documents for early phase products as
well as those who will review these
documents
£ Regulatory affairs workers who will need
to deal with submissions covering early
phase products.
What you get: