2014 - 2-day In-person Seminar on The Drug Approval Process: Preparation and Processing of INDs and NDAs at Zurich, Switzerland

Overview:
This seminar presents all the requirements to obtain FDA permission to market a Drug product in the USA. To find out the fastest and most cost-efficient way onto the USA marketplace this seminar is a must. This seminar introduces FDA and its laws, regulations, policies and guidelines. Starting with Drug development this seminar continues with discussions on the testing requirements for new chemical entities (NCE) and the IND system which leads to Drug clinical testing. Discuss is the format and contents of an IND. All Phases of clinical testing are covered - Phase 0, Phase 1, Phase 2, Phase 3 and Phase 4 testing. Then the NDA system is addressed. The format and content of an NDA are covered. The FDA submission review system is covered for INDs and NDAs. Also addressed are FDA post-approval requirements. With this seminar attendees get a better understanding of the FDA Drug Approval Process and the underlying scientific and regulatory principles involved.
Why should you attend?
? Learn about FDA
? Learn about FDA laws, regulation, policies and guidelines
? Learn about the fastest and most cost-efficient way onto the USA marketplace
? Learn about Drug development
? Learn about the Drug approval process
? Learn about testing requirements for new Drugs
? Learn about the IND process
? Learn about format and content of an IND
? Learn about clinical testing - Phase 0, Phase 1, Phase 2, Phase 3 and Phase 4
? Learn about the NDA process
? Learn about the format and content of a NDA
? Learn about FDA submission review process
? Learn about annual reports
? Learn about post-approval requirements
Areas Covered in the Session:
? Learn about the entire FDA Drug Approval Process
? Requirements for testing of new molecules
? Learn about INDs
? Learn about human clinical trials
? Learn about NDAs
? Learn about FDA review of submissions
Who will benefit:
? Regulatory Affairs Personnel
? Quality Personnel
? Research and Development Personnel
? Legal Personnel
? Manufacturing Personnel
? Clinical Personnel
? Technical Personnel
? Project Managers
? Other personnel who require an understanding of the FDA Drug Approval Process
Course Outline:
Day One
Lecture 1: Introduction to FDA
? History
? Laws
? Regulations
? Policies
? Guidelines
? Overview of FDA
Lecture 2: Definitions
Lecture 3: Drug Classification
? New Drug, Biologic or Generic Drug
? Drug status and strategy
Lecture 4: Drug Development Process
? Drug development outline
Lecture 5: IND Process
? IND format and content
? FDA Form 1571
? FDA IND submission review process
? IND amendments
Day Two
Lecture 6: Drug Clinical Trials
? FDA clinical logic/rationale
? Phase 0 Clinical Studies
? Phase 1 Clinical Studies
? Phase 2 Clinical Studies
? Phase 3 Clinical Studies
? Phase 4 Clinical Studies
Lecture 7: NDA Process
? NDA format and content
? FDA Form 356(h)
? FDA NDA submission review process
? NDA amendments
Lecture 8: Post-Approval Requirements
? Requirements of the approval letter
? Registration/Listing
? NDA Supplements
Speaker Profile:
Albert Ghignone, Chief Executive Officer and President, AAG Incorporated
Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, and regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. He lectures throughout the world on numerous FDA related matters. He is a consultant to FDA and trains FDA Field Force (those who conduct FDA inspections) on GCP, GLP and GMP).
Location: Zurich, Switzerland Date: December 8th & 9th 2014 Time: 9:00 AM to 6:00 PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland
Price: $1,595.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until November 15, Early Bird Price: $1,595.00
From November 16 to December 06, Regular Price: $1,795.00
Registration Link: http://bit.ly/TheDrugApproval
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel,
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Phone: 1800 447 9407
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http://www.globalcompliancepanel.com
Email: support-AT-globalcompliancepanel.com