ICH Training

Upcoming Training Events

27-29 June 2011, Arusha, Tanzania

SADC training workshop on the ICH Q7 Guideline

30-31 May 2011, Kuala Lumpur, Malaysia

ASEAN workshop on the ICH Q5C Guideline

ICH Past Training Events

As part of ICH's strategy on training and capacity-building, the materials from training events are made available on the ICH website in order to expand as broadly as possible the benefits of such training events.

25 April 2011, Tokyo, Japan.

ICH Quality Q8/Q9/Q10 training follow up in Japan

19-20 April 2011, Riyadh, Saudi Arabia

GCC training workshop on ICH Q5A to Q5E Guidelines

2-4 June, 6-8 October and 27-29 October 2010, respectively in Tallinn, Washington DC and Tokyo

ICH Quality IWG training on Q8/Q9/Q10 Guidelines

26-28 July 2010, Kuala Lumpur, Malaysia

ASEAN training on ICH Q8/Q9/Q10 Guidelines

17-19 March 2010, Kuala Lumpur, Malaysia

ASEAN workshop on MedDRA and its Application in Safety Drug Monitoring

2-6 March 2009, Bangkok, Thailand

APEC LSIF/ Thai FDA advanced workshop on Good Clinical Practice (GCP) / Clinical Research Inspection

2-6 February 2009, Bangkok, Thailand

APEC LSIF/ Thai FDA advanced workshop on Review of Drug Development in Clinical Trials

3-5 December 2008, Beijing, China

APEC LSIF/ JCCT on Implementation of ICH Q8/Q9/Q10 and Other Quality Guidelines

27-30 May 2008, Bangkok, Thailand

APEC LSIF/ Thai FDA preliminary workshop on Good Clinical Practice (GCP) / Clinical Research Inspection

17-21 March 2008, Bangkok, Thailand

APEC LSIF/ Thai FDA preliminary workshop on Review of Drug Development in Clinical Trials

• ICH Guidelines

• /Work Products
• /

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories.

Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety Guidelines

ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

Efficacy Guidelines

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.

Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

Business English: A Complete Guide to Developing an Effective Business Writing Style.
by: Andrea B. Geffner

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Accelerating Your Development as a Leader: A Guide for Leaders and their Managers.
by: Robert Barner

"In this book, Dr. Barner has successfully addressed a growing talent management issue, namely the need for preparing today's leaders to move faster through the leadership pipeline. This book will prove invaluable to any organization that is trying to encourage self-directed development, while enlisting the support of managers as coaching advisors. Easy to follow, with detailed suggestions, this is a must read for leaders, managers, and HR professionals who are striving to rapidly grow their leadership talent base. Strongly recommended!"

—Samir Gupte, vice president, Enterprise Function Human Resources, Darden

"Effective leadership continues to be the most critical component to business success while remaining one of the most elusive concepts to understand. Dr. Barner has taken this complex subject and made it meaningful to leaders while providing helpful insights for practitioners. Through simple and practical techniques, this book provides a roadmap for accelerating leadership development and building a personal brand for success. Whether you're a business leader or an Executive Coach, this book will serve as a catalyst to improving your own effectiveness and that of those you touch."
—Kirk Thor, Ph.D., vice president, Talent Management, JC Penney

"Another homerun by Bob Barner! Leaders don't become leaders by accident nor do they move to the next level by accident. You've got to have a plan, and I know of no better guidance in developing one than Accelerating Your Development as a Leader. It is comprehensive, removes the guesswork, and will surely increase your momentum."
—Cass Wheeler, strategic consultant, coach, speaker and former CEO of The American Heart Association; and author, You've Got to Have Heart

"Bob Barner's experience as a coach, corporate leader, and academician shines in Accelerating Your Development as a Leader. He outlines a practical approach to jump-starting career development work built on a foundation of sound research and trusted application."
—Michael Fischer, vice-president, organization development and talent management, Energy Future Holdings

TABLE OF CONTENTS

PART I: PARTICIPANT'S GUIDE.

Participant's Preface.

1 Managing a Company of One.

2 Closing the Gap.

3 Building Your Plan.

4 Leveraging Developmental Assignments.

5 Accelerating Your Learning.

6 Managing Your Personal Brand.

PART II: LEADER'S GUIDE.

Leader's Preface.

1 The What and the Why of Managerial Coaching.

2 How to Implement Coaching.

3 Helping Others to Identify Developmental Gaps.

4 Helping Others Build Their Plans.

5 Helping Others Leverage Developmental Assignments.

6 Helping Others Accelerate On-the-Job Learning.

7 Coaching Others on Brand Management.

About the Author.

Index.

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The Project Management Advisor: 18 Major Project Screw-ups, and How to Cut Them off at the Pass

The Project Management Advisor: 18 Major Project Screw-ups, and How to Cut Them off at the Pass.
By Lonnie Pacelli

• Publisher: Prentice Hall

• Number Of Pages: 192
• Publication Date: 2004-09-03
• ISBN-10 / ASIN: 0131490478
• ISBN-13 / EAN: 9780131490475

Product Description:

This is your complete, hands-on guide to saving projects in trouble.

Drawing on 20 years of frontline project management experience, Lonnie Pacelli identifies the 18 most pervasive causes of project failure: their causes, early warning signs, and how to fix them before it's too late.

Here's just some of what you'll learn...

• ...how to focus on the right problem, find and keep the right sponsors, realistically determine scope, uncover hidden risks, write more effective project plans...
• ...involve the right people, get your whole team on the same page...
• ...deal with vendors who don't deliver... manage and minimize cost overruns...
• ...communicate more effectively...test right, train right...
• ...streamline that last, endless 10% and finish strong...
• ...and more...
• ...a whole lot more.

If you're a working project manager, consultant, or team leader, this book is your secret weapon. It's fast. Relevant. Practical. Easy to read. Easy to use. Above all: it works.

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Handbook of Forensic Drug Analysis
By Fred Smith
Publisher: Academic Press
Number Of Pages: 584
Publication Date: 2004-12-13
ISBN-10 / ASIN: 0126506418
ISBN-13 / EAN: 9780126506419
Binding: Hardcover

The Handbook of Forensic Drug Analysis provides in-depth, up-to-date methods and results of forensic drug analyses. Chapters written by leading researchers in the field discuss the various forms of the drug as well as the origin and nature of samples. How to perform various tests, the use of best practices, and the analysis of results are discussed in detail. Numerous forensic and chemical analytic techniques are covered including immunoassay, gas chromatography, and mass spectrometry.

This complete volume is the only compendium of its kind on illicit drugs and analysis and should serve as a widely used reference for professionals. In addition, it can also be used as a standard textbook for graduate courses in forensic science.

- Contributed to by leading scientists from around the world.
- The only analysis book dedicated to illicit drugs of abuse
- Comprehensive coverage of sampling methods and various forms of analysis

Quality Systems and Controls for Pharmaceuticals
By Dipak Kumar Sarker

Publisher: Wiley
Number Of Pages: 204
Publication Date: 2008-10-20
ISBN-10 / ASIN: 0470056924
ISBN-13 / EAN: 9780470056929
Binding: Hardcover

Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.

Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice.

The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

Description
This practical manual and standard reference work provides an authoritative source of analytical data for drugs and related substances. It is intended for scientists faced with the difficult problem of identifying an unknown drug in a pharmaceutical product, in a sample of tissue or body fluid from a living patient or in postmortem material. It is intended to be a useful requirement for all forensic and crime laboratories, toxicologists, clinical and analytical chemists, pathologists, poison information centres and clinical pharmacology departments.

ISBN: 9780853691662

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