Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products

Transcription

1 Microrite, Inc. brings you this unique learning experience in Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products; Part of Microrite s step-by-step webinar series. Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products ICH stability guidelines describe requirements for commercial drug products, but how much data is necessary for stability testing of early phase clinical products? What are the analytical requirements? At what stage of development should you transition into ICH compliant stability testing? When? July 30 th, :30pm to 3:30pm Eastern Standard Time Which industries does this webinar apply to? Pharmaceuticals, Biotechnology, Drug Device Combination Products, In Vitro Diagnostics, and Cosmetics Who will benefit? Quality Assurance, Quality Control, Materials, Manufacturing, Microbiology, R&D and Training personnel

2 July 30 th, 2014 Benefits to the participants: Differences in stability programs for phases of pre-clinical and clinical testing Regulatory requirements for stability testing Analytical methods for stability determination Stability sample storage requirements Stability in toxicology formulations Phase 1 stability program Phase 2 stability program Who will be teaching? Carl Wilson is the founder and President of International BioPharmaceutical Consulting, Inc. He has independently provided Quality Systems consulting services for the past 17 years to domestic and international clients including companies from the start-up phase to big pharma. Quality systems strategies have successfully supported regulatory submissions for more than ten approved biologic and small molecule therapeutics. In addition to providing expertise to the pharmaceutical and biotechnology industries commensurate with the phase of clinical to commercial product development he has conducted training seminars and workshops for stability program development.

3 REGISTRATION FORM Stability Testing for Pre-Clinical and Early Phase Clinical Drug Products Personal Information of One Registrant Last Name: Mr. Ms. Dr. First Name: Job Title: Organization: Mailing Address: Telephone: Fee: (see fee structure below, all costs are per attendee) 1 attendee $ attendees $180 (per attendee)(20% Discount) 6-10 attendees $153 (per attendee)(32% Discount) 11 or more attendees $135 (per attendee)(40% Discount) Method of Payment: Credit Card and Check payments only. Attendees can register and make payments on Microrite s website: or complete this form and fax to Check payments must be cleared before the webinar date. If you have any questions regarding payment methods feel free to contact Microrite at or send your enquiry to webinars@microrite.com. Confirmation of registration will be sent via . For credit card payment on website, a payment receipt will be considered as confirmation of registration. For credit card information faxed to Microrite an confirmation will be sent with a copy of payment receipt. Please call in due time if confirmation is not received after payment. Webinar cancellation must be received 3 business days prior to the webinar less a 10% service fee, cancellation requests will be accepted via only. All refund requests must be made by the organizations primary contact or credit card holder. Refunds will be credited to the original credit card used to purchase the webinar.

4 Additional Attendees First and Last Name

5 Choose One (Place X) VISA Master Card American Express Card Holder s Name Address of Card Holder: Enter firm address for corporate card or personal address for personal card Street: City/State: Zip Code: Country: Contact Ph No & Card Number: Expiration(Month/Year): Amount (US Dollars): Signature: Name of Attendee(s) Referred by: Kindly note the name of the company or person that referred you to this workshop. We would like to thank them.