مرحباً اخوتي جميعاًفي بداية افتتاح هذا القسم حبيت اقدم لكم مجموعة متميزة من الدورات العالمية في الصناعات الدوائية علماً بأنها كثيرة وعلى مدار العام واخترت لكم الاهم والاكثر شيوعاً وفي الشهر oct. واذا فاتكم لا يهم لانها تقام في اكثر من فترة ....وسوف اقدم التفاصيل لمن يهمه هذا الامر ...والدورات الاكثر شهرة ::
1-FDA Inspections: What To Expect And How To Prepareوصف الدورة Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format. The following are examples of some of the issues addressed during the course:What your organization can do to prepare for the inspection What information can the FDA request during an inspection Can a Warning Letter be issued immediately after an FDA inspection When can the FDA take action without issuing a Warning Letter What does the FDA look for during inspections How does the FDA classify a recall What are the timeframes for the U.S. DOJ's and FDA's handling of clear criminal fraud cases What type of documentation is required and what is the correct format What do the FDA's export regulations mean to your firm What types of cases does the FDA refer to the DOJ for prosecution When can the FDA suspend, deny or withdraw abbreviated new drug applications (ANDAs) How to respond to FDA actions Under what conditions can the FDA debar companies and individuals What to do after the FDA has taken action المكان والاسعار ::The Desmond Hotel & Conference Center, Malvern, PA -- Oct. 11 & 12, 2007 -- $1750.00:::::::::::::::::::::::::::::::::::::::2-cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologicsوصف الدورةThis course is intended to give participants a thorough grounding in the Current Good Manufacturing Practices for both the US and Europe. Day 1 provides a comprehensive introduction to international CGMPs and is also a good refresher for those already experienced in CGMP compliance. Day 2 covers intermediate level topics such as compliance “hot spots,” deviations, out-of-specification results, risk analysis, and auditing for compliance. Day 3 covers advanced topics such as compliance during development, effective compliance strategies, current hot topics, predicting regulatory trends, and shortcuts for staying at the forefront of compliance knowledge. The course concludes with an interactive exercise designed to test your knowledge of CGMP regulations.Additional benefits of this class include:Learning not just from the course director, but tapping into the knowledge of your peers: Participants may anonymously submit their top CGMP challenges, problems, and issues for classroom discussion Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 20 years of industry experience, more than 8 years of consulting experience, and over 10 years directing CGMP training courses Participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and moreالمكان والاسعار ::The Hilton Hotel, Orange County/Costa Mesa, CA -- Sep. 26 - 28, 2007 -- $2050.00The Desmond Hotel & Conference Center, Malvern, PA -- Oct. 22 - 24, 2007 -- $2050.00:::::::::::::::::::::::::::::::::::::::::::3- The Drug Development Process - From Discovery to Commercializationوصف الدورةThe drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.Topics include:Basic concepts of drug discovery and testing Scientific, regulatory, and management framework for modern pharmaceutical development Pre-clinical study requirements and how information gathered is used for human clinical studies The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase The economics of drug development Cost/benefit issues in clinical development Discovery and development milestones The IND Process The NDA Process FDA Interactions – Application review and approval process Patents and exclusivity The rationale of government regulations and how they effect the development process The relationship between the Code of Federal Regulations and ICH GCP Designing optimal clinical trials Drug labeling, marketing, and pharmacoeconomic studies Project management cross functional teams during the development process المكان والاسعار :The Burlington Hotel, Dublin, Ireland -- Sep. 24 - 26, 2007 -- $2050.00 The Desmond Hotel & Conference Center, Malvern, PA -- Nov. 07 - 09, 2007 -- $2050.00
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1-FDA Inspections: What To Expect And How To Prepareوصف الدورة Personnel attending this interactive program will have an opportunity to learn how to prepare for an FDA inspection, what to expect during interaction with FDA officials and how to respond to FDA observations. Additionally this course is a good refresher for all personnel involved in the FDA inspection process and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format. The following are examples of some of the issues addressed during the course:What your organization can do to prepare for the inspection What information can the FDA request during an inspection Can a Warning Letter be issued immediately after an FDA inspection When can the FDA take action without issuing a Warning Letter What does the FDA look for during inspections How does the FDA classify a recall What are the timeframes for the U.S. DOJ's and FDA's handling of clear criminal fraud cases What type of documentation is required and what is the correct format What do the FDA's export regulations mean to your firm What types of cases does the FDA refer to the DOJ for prosecution When can the FDA suspend, deny or withdraw abbreviated new drug applications (ANDAs) How to respond to FDA actions Under what conditions can the FDA debar companies and individuals What to do after the FDA has taken action المكان والاسعار ::The Desmond Hotel & Conference Center, Malvern, PA -- Oct. 11 & 12, 2007 -- $1750.00:::::::::::::::::::::::::::::::::::::::2-cGMP for Quality Assurance and Quality Control of Pharmaceuticals, Biopharmaceuticals, and Biologicsوصف الدورةThis course is intended to give participants a thorough grounding in the Current Good Manufacturing Practices for both the US and Europe. Day 1 provides a comprehensive introduction to international CGMPs and is also a good refresher for those already experienced in CGMP compliance. Day 2 covers intermediate level topics such as compliance “hot spots,” deviations, out-of-specification results, risk analysis, and auditing for compliance. Day 3 covers advanced topics such as compliance during development, effective compliance strategies, current hot topics, predicting regulatory trends, and shortcuts for staying at the forefront of compliance knowledge. The course concludes with an interactive exercise designed to test your knowledge of CGMP regulations.Additional benefits of this class include:Learning not just from the course director, but tapping into the knowledge of your peers: Participants may anonymously submit their top CGMP challenges, problems, and issues for classroom discussion Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 20 years of industry experience, more than 8 years of consulting experience, and over 10 years directing CGMP training courses Participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and moreالمكان والاسعار ::The Hilton Hotel, Orange County/Costa Mesa, CA -- Sep. 26 - 28, 2007 -- $2050.00The Desmond Hotel & Conference Center, Malvern, PA -- Oct. 22 - 24, 2007 -- $2050.00:::::::::::::::::::::::::::::::::::::::::::3- The Drug Development Process - From Discovery to Commercializationوصف الدورةThe drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.Topics include:Basic concepts of drug discovery and testing Scientific, regulatory, and management framework for modern pharmaceutical development Pre-clinical study requirements and how information gathered is used for human clinical studies The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase The economics of drug development Cost/benefit issues in clinical development Discovery and development milestones The IND Process The NDA Process FDA Interactions – Application review and approval process Patents and exclusivity The rationale of government regulations and how they effect the development process The relationship between the Code of Federal Regulations and ICH GCP Designing optimal clinical trials Drug labeling, marketing, and pharmacoeconomic studies Project management cross functional teams during the development process المكان والاسعار :The Burlington Hotel, Dublin, Ireland -- Sep. 24 - 26, 2007 -- $2050.00 The Desmond Hotel & Conference Center, Malvern, PA -- Nov. 07 - 09, 2007 -- $2050.00
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