GMP And Regulatory Expectations For Early IND Products – US

Feb 10, 18 GMP And Regulatory Expectations For Early IND Products – US

GMP And Regulatory Expectations For Early IND Products – US Seminar 2012 at San Diego

Overview: Any pharmaceutical employee who must cope with items both in early and latter phases of advancement should attend this program to become alert to the regulatory requirements which will affect operations coping with these products.

Any pharmaceutical worker who need to cope with products both in early and latter phases of development should attend this program to become alert to the regulatory requirements which will affect operations coping with these products. The adjustments to the GMPs for early stage items have altered the GMPs so concerning reduce requirements to permit more efficient work. Simultaneously some of the stuff that can happen to have changed, possess not really, and the pharmaceutical employee should become aware of this. This training course will present, in a single place, the rules and guidelines that connect with early phase items. In some instances these will never be rules, but desires that, if met, increase the performance of activities as something proceeds through the advancement process. The training course will present these products in the region of product advancement from the idea of R & D actions to the completion of Stage 2 clinical trials.

Areas Covered in the Program:

Day 1, April 5, 2012

Lecture 1: Very Early StagesThe dependence on documentation of issues which will affect downstream ramifications of ICH Q8Influence on R & D activitiesRisk evaluation and style control at this time.Lecture 2: GLP RequirementsAnimal studiesToxicology and pharmacokinetics.Estimating the utmost Safe Starting DoseA overview of the guidance record.Lecture 3: Early Pre-IND StudiesUnderstanding exploratory StudiesDefinitions and the IND which will be withdrawn.Orphan DrugsDrugs studied beneath the Pet RuleWhat they are and how exactly to conduct the research.Lecture 4: Meetings and Finding your way through the INDInformation necessary for the Phase 1 INDThe CMC requirements which will be -IND Meetings with FDA

Day 2, April 6, 2012

Lecture 5: GMPs for Phase 1 IND products

The scope of the guidance documentThe second guidance record within the GMPs.Lecture 6: GMPs for Phase 1 continuedA display covering what GMPs are required as of this has been omitted from the GMPs for Stage 1.Lecture 7: Requirements for Stage 2 INDsThe complete GMPs resume, but carry out they?Phase 2 research and the changeover to complete requirements.Lecture 8: Finding your way through IND MeetingsPhase 1 meetingsPre-phase 2 meetingsPhase 2 meetings

Who’ll benefit:DirectorsManagersSupervisors, and lead employees in Regulatory AffairsQuality Assurance and Quality ControlWorkers who’ll prepare GMP records for early phase items as well as those that will review these documentsRegulatory affairs employees who’ll need to cope with submissions covering early stage products.

Steven S. Kuwahara, Ph.D. may be the founder and Principal of GXP BioTechnology LLC, a consulting company that functions in the areas included in the GLP and GMP of medications, biologics, and nutraceuticals. Steve provides over 30 years of knowledge in supervising quality control laboratories, including an pet testing service, and in executing GLP and GMP audits of inner and external assessment laboratories . Steve provides participated in the advancement of medications and biologicals through all phases of scientific research and final item production.

Date & Venue:

April 05th and April 06th 2012 at Courtyard by Marriott NORTH PARK Downtown8 AM PDT to 5 PM PDT

Price: $1,695.00

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