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 All rights are reserved © GlobalCompliancePanel. 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 Day 2 - 6th April 2012 Lecture 1: Very Early Stages Lecture 5: GMPs for Phase 1 IND „ The need for documentation of matters that will products affect downstream work. „ The scope of the guidance document „ The effects of ICH Q8 – Impact on R & D activities „ The second guidance document covering the GMPs – Risk analysis and design control at this stage Lecture 6: GMPs for Phase 1 continued Lecture 2: GLP requirements „ A presentation covering what GMPs are „ Animal studies required at this stage. – Toxicology and pharmacokinetics „ What has been omitted from the GMPs for „ Estimating the Maximum Safe Starting Dose Phase 1 – A review of the guidance document Lecture 7: Requirements for Phase 2 Lecture 3: Early Pre-IND Studies INDs „ Understanding exploratory Studies „ The full GMPs resume, but do they? – Definitions and the IND that will be withdrawn „ Phase 2 studies and the transition to full GMPs. „ Orphan Drugs „ CMC requirements „ Drugs studied under the Animal Rule – What they are and how to conduct the studies Lecture 8: Preparing for IND Meetings Lecture 4: Meetings and Preparing for „ Phase 1 meetings the IND „ Pre-phase 2 meetings „ Information required for the Phase 1 IND „ Phase 2 meetings – The CMC requirements that will be needed. „ Pre-IND Meetings with FDA www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. USA Seminar 2012 at San Diego What you get: 1. Learning Objectives Pricing List: 2. Participation certificates 1. Price for One Delegate pass 3. Interactive sessions with the US expert $1895 4. Post event email assistance to your queries. (Between March 23th to April 25th) 5. Special price on future purchase of web based trainings. ----------------------------------------- 6. Special price on future consulting or expertise services. 2. Early bird price for one Delegate 7. Special price on future seminars by GlobalCompliancePanel. pass $1695 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, (Between February 16th to March 22th) notepad and pen. ----------------------------------------- 9. Networking with industry's top notch professionals 3. For discounts on multiple registrations, contact customer care at 1800 447 9407 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 v Register online. Use your American Express, Visa or MasterCard documents for early phase products as v For group discount of more than 5 attendees call 800-447-9407 well as those who will review these v Call +1 - 800-447-9407 or Fax your PO: 302-288-6884 documents £ Regulatory affairs workers who will need v Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL, to deal with submissions covering early 6552 Palisades Dr. Centreville, VA 20121 phase products. Contact Information: Event Coordinator Toll free: 1800 447 9407 Kindly get in touch with us for Fax: 302 288 6884 Email: firstname.lastname@example.org any help or information. GlobalCompliancePanel Look forward to meeting you NetZealous at the seminar 1000 N West Street, Team GlobalCompliancePanel Suite 1200, Wilmington, DE 19801.. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.