Net Zealous
USA Seminar 2012 at San Diego
GMP and Regulatory Expectations for Early IND Products by
Dr Steven S. Kuwahara
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. www.globalcompliancepanel.com
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USA Seminar 2012 at San Diego Dr Steven S. Kuwahara Founder & Principal, GXP Biotechnology, LLC
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.
Past Seminars
Date and Venue: April 5th and 6th, 2012 at San Diego Will be announced soon
USA Seminar 2012 at San Diego Seminar Content:
Conference timings: 9 AM PDT to 5 PM PDT
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. Day 1 - 5th April 2012
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
Day 2 - 6th April 2012
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 Lecture 2: GLP requirements „ Animal studies – Toxicology and pharmacokinetics „ Estimating the Maximum Safe Starting Dose
„ A presentation covering what GMPs are
required at this stage. „ What has been omitted from the GMPs for
Phase 1
– 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
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
– What they are and how to conduct the
studies
Lecture 4: Meetings and Preparing for the IND „ Information required for the Phase 1 IND
Lecture 8: Preparing for IND Meetings „ Phase 1 meetings „ Pre-phase 2 meetings „ Phase 2 meetings
– The CMC requirements that will be needed. „ Pre-IND Meetings with FDA www.globalcompliancepanel.com
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USA Seminar 2012 at San Diego What you get:
Pricing List:
1. Learning Objectives
1. Price for One Delegate pass $1895
2. Participation certificates 3. Interactive sessions with the US expert
(Between March 23th to April 25th)
4. Post event email assistance to your queries.
----------------------------------------2. Early bird price for one Delegate pass $1695
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.
(Between February 16th to March 22th)
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
----------------------------------------3. For discounts on multiple registrations, contact customer care at 1800 447 9407
notepad and pen. 9. Networking with industry's top notch professionals
Companies that will benefit: † Small Molecule Drug Companies
Professionals who will benefit:
† Biologic Companies
£ Directors
† API and Generics Manufacturers
£ Managers £ Supervisors, and lead workers in
Regulatory Affairs
How to Register:
£ Quality Assurance and Quality Control £ Workers who will prepare GMP
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Register online. Use your American Express, Visa or MasterCard
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For group discount of more than 5 attendees call 800-447-9407
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Call +1 - 800-447-9407 or Fax your PO: 302-288-6884
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Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL, 6552 Palisades Dr. Centreville, VA 20121
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.
Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com GlobalCompliancePanel NetZealous 1000 N West Street,
Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel
Suite 1200, Wilmington, DE 19801..
www.globalcompliancepanel.com
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