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• Sales Rank: #5570378 in Books
• Published on: 1971
• Binding: Sheet music

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International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.

• The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels)
• The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization
• The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

• Sales Rank: #3738191 in Books
• Published on: 2013-12-24
• Original language: English
• Number of items: 1
• Dimensions: 9.00" h x .98" w x 6.00" l, 2.08 pounds
• Binding: Hardcover
• 376 pages

Review

“…thoroughly covers the current state of international cooperative initiatives, underlying principles, why cooperation is important, and productive objectives for the future… This book has been selected for The First Clinical Research Bookshelf Essential reading for clinical research professionals.”--Journal of Clinical Research Best Practices, July 2014

From the Back Cover

Globalization is a reality of the 21st century.  The development, manufacture and distribution of medicines have been internationalized.  This increased globalization has fundamentally changed the environment for regulating medicines and created unique regulatory challenges for all stakeholders.  The regulatory paradigm has indeed changed from national to international and international pharmaceutical norms and standards are more important than ever before.  International cooperation, convergence and harmonization of pharmaceutical regulations has become the only clear choice to meet the fundamental human right to have access to high quality, safe and effective medicines in both developed and developing countries.

In this context, many cooperative initiatives have been established at the bilateral, regional and global levels and harmonization efforts have been enhanced.  All of these initiatives have taken a variety of forms, from informal cooperation to full integration of regulatory systems.

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of this complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III).  All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfil the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector.  This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.

This book features:

• The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels)
• The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization
• The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

About the Author
Dr. Pierre-Louis Lezotre specializes in global regulatory strategy, and is recognized for his passion and expertise
on international cooperation, convergence, and harmonization of regulations for pharmaceutical
and biotechnology products. He has worked in different cultural environments and lived in
both Europe and the United States.

Dr. Lezotre studied biology (University of Sciences, Saint-Etienne, France)
and drug development (University of Pharmacy, Montpellier, France) from
1992 to 1998. He then received his Master in Regulatory Sciences in 1999 (University
of Pharmacy, Lille, France). He also recently completed his PhD in Law with honors (Doctoral
School of “Law, Politics and Management,” University of Law, Lille, France).

Since 1998, Dr. Lezotre has worked for several international pharmaceutical and biotechnology
companies, with increasing levels of responsibility. He has served as a regional and
then global regulatory leader for small molecule and biologic/biotech programs in various
stages of research and development (from early discovery to life cycle management). He
successfully led many global regulatory teams in supporting global registrations of major
products and numerous development projects in several therapeutic areas, including
dermatology, urology, neurology, and pain. He has been responsible for communications
with worldwide Drug Regulatory Authorities and has also worked with external partners/
companies through co-development agreements and business development programs.

Dr. Lezotre has recently been invited to teach courses on international regulation in the
Regulatory Sciences programs of the University of Southern California (USC).

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OST: Clinical Medicine for the MRCP PACES: Volume 1: Core Clinical Skills (Oxford Speciality Training), by Gautam Mehta, Bilal Iqbal

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Volume 1 of a two volume MRCP text, this book includes cases which mimic the style and approach of the MRCP PACES exam. Clinical Medicine for MRCP PACES will equip the candidate attempting the MRCP examination with the skills and knowledge necessary for success, and will also provide an overview of evidence-based medicine for competency-based training. Throughout this and Volume 2, the authors explore all aspects of the candidate's performance, from clinical examination, to presentation, communication and medical ethics and up-to-date clinical evidence.

Volume 1 includes over 150 cases and covers Stations 1, 3 and 5: Station 1 covers the respiratory and abdominal systems; Station 3 covers the cardiovascular and central nervous systems; Station 5 includes 20 Brief Clinical Consultations and supplementary cases covering ophthalmology, dermatology, endocrine and locomotor presentations.

Throughout the book, the cases begin with the case presentation, followed by extensive clinical notes for each case. Each case also includes questions commonly asked by the examiners with suggested evidence-based answers and relevant bibliography. Station 5 Brief Clinical Consultations include a standardized approach to preparation and provide a concise summary of the focused history, examination, diagnosis and guidance on how to feedback to both the patient and the examiner.

Visit our website for details of our range of titles for MRCP and more in the Oxford Specialty Training series at www.oup.com/uk/medicine/ost http://www.oup.com/uk/medicine/ost
Advance praise for Clinical Medicine for MRCP PACES:
"The authors have produced two volumes packed with the information needed to pass PACES and to practise high quality medicine. While written specifically for those aspiring to be physicians these volumes deserve to be widely read by all with an interest in clinical medicine. Candidates in particular and patients have good reason to welcome these volumes."
Sir Graeme Catto

• Sales Rank: #1126277 in Books
• Published on: 2010-09-13
• Original language: English
• Number of items: 1
• Dimensions: 6.25" h x 1.50" w x 9.25" l, 2.05 pounds
• Binding: Paperback
• 664 pages

Review
Advance praise for Clinical Medicine for MRCP PACES: "The authors have produced two volumes packed with the information needed to pass PACES and to practise high quality medicine. While written specifically for those aspiring to be physicians these volumes deserve to be widely read by all with an interest in clinical medicine. Candidates in particular and patients have good reason to welcome these volumes." --Sir Graeme Catto

About the Author

Dr Gautam Mehta qualified from Southampton University in 2001 and underwent postgraduate training at Hammersmith, Royal Free, St Mary's, and Charing Cross Hospitals. He was the youngest appointee to the North West Thames Gastroenterology and Internal Medicine registrar rotation, and is currently a Wellcome Trust Research Fellow at the Institute of Hepatology, University College London.
Gautam is widely published and regularly teaches on MRCP PACES preparation courses. He has an extensive background in medical education, having completed a Fellowship in Medical Education with the London Deanery, and undertaking the Masters in Clinical Education programme at the Institute of Education. Gautam is also an examiner for medical finals at Barts & the London Medical School. Dr Bilal Iqbal is currently Specialist Registrar in Cardiology at Hammersmith Hospital, London.

Most helpful customer reviews

0 of 0 people found the following review helpful.
Good clinical aid
By Au_icu_Reg
This "Core clinical skills" was instrumental in guiding me during my Basic physician training in Adult Internal medicine.
I read it before and after my duties, cross-checking what I missed and revising what I knew.
By the end of my first three months, using this book, I didn't need it anymore as it had thought me the basics that i needed to know, to be a successful physician.
I also bought an extra copy and gave to a colleague who was struggling with his clinical exams. Looking forward to hearing of his success at the next clinical exams.

See all 1 customer reviews...

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[N424.Ebook] Download Ebook Ending Stress: A Practical Guide to Nondual Meditation and Therapy (Personal Transformation - Spiritual & Mental Healing Book 1), by Jonat

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Do you want to eliminate stress in your life?This manual shows you the way!

This highly practical guide shows you clearly and directly how to remove stress, anger, fear and worry by becoming more realistic, using 2,500 year old meditation and therapy tools and inspired by masters of nondual and Buddhist wisdom traditions including Dzogchen, Mahamudra, Zen, Madhyamika, Advaita and Tao. Jonathan Harrison teaches nondual and Buddhist meditation and psychology.

The guide explains how mental stress is created and how to remove it from your life in all its forms including anger, anxiety, disappointment, discontent, dissatisfaction, dread, envy, fear, frustration, guilt, humiliation, impatience, insult, misery, mistrust, regret, tension and worry.

Jonathan Harrison shows how, in order to see how stress is created, you need to understand three things:

- The way you think about things:

You see the world as structured, split into separate parts which may be in conflict. Your particular mental structures consisting of your personal opinions and concepts is the result of many factors including your genetic makeup, parental upbringing, social and cultural environments and the way you have perceived, internalized and acted on your experiences. These mental structures develop and change throughout your life. The world as you see it is largely a reflection of your mental history. What you think is an original creation of your mind.

- The way things really are:

Reality, the world as it is, is neither inherently split (dualistic), nor unified, neither structured nor unstructured. It just is. This is so simple that most people do not understand it.

- Ending stress

It is enough to grasp deeply how things really work. The past has gone, is unalterable, the future is non-existent except as your present expectations, and “now” is already here. Within this realization, true rest occurs naturally. This is non-meditation, natural meditation or “resting in natural awareness” as Longchen Rabjam, the renowned Tibetan yogi and Dzogchen meditation master, put it.

By recognizing the nature of reality you are able to live, love and benefit yourself and others more easily, as you no longer experience the frustration of trying to grasp at imagined parts of your experience or trying to remove them.

Scroll up and grab a copy today.

• Sales Rank: #623271 in eBooks
• Published on: 2014-08-06
• Released on: 2014-08-06
• Format: Kindle eBook

Review
Dr. Peter Fenner:"The guide offers a lucid introduction to the ultimate state and outlines clear practices to realization. Jonathan's analysis of the dualistic mind that produces all our suffering is compelling and I delight in the way he continually points us back to the inherent inner wisdom that is at the core of every conscious being." 
Dr. Stephen Fulder:"Learning meditation is not easy and it is not difficult. It is helpful if there is some good teaching to set us on the right path. This is where this book comes in. Jonathan Harrison has written a wonderful manual which is remarkable in its directness, simplicity, and sharpness. It offers very concise instructions not only on meditation but also on different ways of viewing ourselves and the world."

About the Author
Jonathan Harrison was born in Manchester, England. Following completion of degrees in physics and mathematics at the University of Edinburgh, Scotland he moved to Israel where he has lived since 1969. In 1997, during a successful career in defense computer engineering and hi tech management he developed a strong interest in western and eastern psychotherapy and in particular Buddhist and nondual methods. He spent several years in meditation, study and practice including a personal retreat at the Tibetan Dzogchen Monastery in southern India. He currently teaches worldwide and writes on nondual wisdom, meditation and mental therapy inspired by masters of traditions including Dzogchen, Mahamudra, Zen, Mahayana, Advaita and Tao. The Hebrew edition of his first book "Know Reality. Find Peace." featured on Israel best seller lists for seven weeks. It is now available in English on Amazon Kindle. Jonathan Harrison writes a regular weekly blog on nondual meditation and the elimination of mental stress. He is married with three children and seven grandchildren.

Most helpful customer reviews

2 of 2 people found the following review helpful.
Controlling your stress, anger, fear as well as worry has never been more enlightening.
By Lazaro
Controlling your stress, anger, fear as well as worry has never been more enlightening.

Truly an astounding book that will captivate the heart, mind and spirit and embark you on a journey through time. The end result will leave you breathless in a better state of being that will enlighten your senses to a level that few are able to travel.

Due to a series of unfortunate events in my life, I had to look for alternatives that could help me become a better person. My solution was meditation. While I am no expert in the field of meditation, having only read about three books on the subject, I have and can say that I have improved my state of being and have found myself more in touch with the world around me.

Looking for a way to grow both in knowledge and improve my meditation techniques I began searching for another book to broaden my horizons. That is when I stumbled across “Know Reality. Find Peace: Removing stress, anger, fear and worry by becoming more realistic. A practical guide to meditation and therapy through nondual and buddhist wisdom traditions.” By Author Jonathan Harrison.

This book has it all, in a comprehensive, easy to follow manner that is not for the feint of heart. Everything from "Stress and its elimination” to “Overcoming anxiety, hope and fear” is discussed and addressed in this book. It is literally a step-by-step walk through on how to get a handle on the world around you and above all yourself. Dzogchen, Mahamudra, Zen, Madhyamika, Advaita and Tao techniques are all applied to combine a fantastic book that I know will stand the test of time.

5 stars and Brilliant work!

4 of 4 people found the following review helpful.
Meditation 101
By Mrs. B
Know Reality, Find Peace. Is that possible? I wasn't sure it was, so I had to buy the book to find out. I've been wanting to do some type of meditation for a while now, I just really was not sure where to even begin to start.

This book is absolutely fantastic, and I already feel like I'm getting a good grasp on the techniques. The author has written a clear and concise book to help us learn to deal with the stress we all face in our daily lives in a very doable and practical manner.

The writing is very good and more importantly, easy to follow and understand. If you are interesting in learning meditation skills, this is definitely the book you want to pick up.

3 of 3 people found the following review helpful.
Meditation Works
By Amelia Wallace
Although the act of meditation may sound simple enough, it is actually more difficult to execute, especially if you've never tried it before. Meditation is the simple act of clearing your mind and body from all thoughts and stresses. The author, Jonathan Harrison has provided this manual to teach the reader how to use meditation to find peace, remove stress and dissolve anger through meditation. We often confuse thoughts with reality, which causes stress. Harrison teaches you how to avoid this confusion so that stress can be virtually eliminated from your life. I think this is a great guide book for anyone wanting to understand the process of meditation---for beginners and veterans alike. Start living your life with less stress---allow this book to show you how.

See all 52 customer reviews...

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