the drug approval process: preparation and processing of inds and ndas

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Global

CompliancePanel

2-day In-person Seminar:

Course "The Drug Approval Process: Preparation and Processing of INDs and NDAs" has been pre-approved byRAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

About GlobalCompliancePanel:

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www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.

Location: | December 8th & 9th 2014Zurich, Switzerland

The Drug Approval Process: Preparation and Processing ofINDs and NDAs

Knowledge, a Way Forward…

By: Albert Ghignone



Global

CompliancePanel


2-day In-person Seminar 2014

Agenda:

Day 1: Day 2:

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

Lecture 1: Drug Clinical Trials

FDA clinical logic/rationale

Phase 0 Clinical Studies





Lecture 2: NDA Process

NDA format and content

FDA Form 356(h)

FDA NDA submission review process

NDA amendments

Lecture 3: Post-Approval Requirements

Requirements of the approval letter

Registration/Listing

NDA Supplements

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 seminarintroduces 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 andguidelines

Learn about the fastest and most cost-efficient wayonto 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 the NDA process



Global

CompliancePanel

GlobalCompliancePanel Seminar Registration Form

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

Price for One Delegate pass Price: $1,595.00

Pricing list:

1. Learning Objectives

2. Participation certificates

3. Interactive sessions with the US expert

4. Post event email assistance to your queries.

5. Special price on future purchase of web based

trainings.

6. Special price on future consulting or expertise

services.

7. Special price on future seminars by

GlobalCompliancePanel.

8. Seminar Kit – includes presentation handout, ID card,

brochure, trainings catalog, notepad and pen.

9. Networking with industry's top notch professionals

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Look forward to meeting youat the seminar

Team GlobalCompliancePanel

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Toll free: +1-800-447-9407Fax: 302 288 6884Email: [email protected]

NetZealous LLC, DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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Knowledge, a Way Forward…

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the drug approval process: preparation and processing of inds and ndas

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