Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

2 avg rating
( 1 ratings by Goodreads )
 
9783527318773: Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
View all copies of this ISBN edition:
 
 

"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." -Microbiology Today, May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

"synopsis" may belong to another edition of this title.

Review:

"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." (Microbiology Today, May 2009)

About the Author:

J.J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company employing several 100 people who develop and manufacture in vitro diagnostic reagents. Dr. Tobin therefore has extensive experience of working within an FDA and European medical device regulatory framework. Gary Walsh is a senior lecturer in industrial biochemistry at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical industry, as well as extensive teaching and non-laboratory based research interests in the pharmaceutical biotechnology arena. He has published a number of books, book chapters and journal articles relevant to this publication. He also teaches elements of pharmaceutical science and regulatory affairs on an annual course provided by the University of Limerick to an international medical device company with a manufactoring facility based in the region.

"About this title" may belong to another edition of this title.

Other Popular Editions of the Same Title

9783527333264: Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Featured Edition

ISBN 10:  3527333266 ISBN 13:  9783527333264
Publisher: Wiley VCH, 2021
Hardcover

Top Search Results from the AbeBooks Marketplace

1.

Tobin, John J.; Walsh, Gary
Published by Wiley-Blackwell, . (2008)
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Hardcover First Edition Quantity Available: 1
Seller:
Writers Den
(Ottawa, ON, Canada)

Book Description Wiley-Blackwell, ., 2008. Hardcover. Condition: New. 1st Edition. Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. New. Seller Inventory # 000360

More information about this seller | Contact this seller

Buy New
67.10
Convert currency

Add to Basket

Shipping: 6.22
From Canada to U.S.A.
Destination, rates & speeds

2.

Jack Tobin
Published by Wiley-VCH 2008-07-09, Weinheim :|Chichester (2008)
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Hardcover Quantity Available: 1
Seller:
Blackwell's
(Oxford, OX, United Kingdom)

Book Description Wiley-VCH 2008-07-09, Weinheim :|Chichester, 2008. hardback. Condition: New. Seller Inventory # 9783527318773

More information about this seller | Contact this seller

Buy New
68.74
Convert currency

Add to Basket

Shipping: 4.99
From United Kingdom to U.S.A.
Destination, rates & speeds

3.

John J. Tobin
Published by Wiley VCH (2008)
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 3
Seller:
Books2Anywhere
(Fairford, GLOS, United Kingdom)

Book Description Wiley VCH, 2008. HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FW-9783527318773

More information about this seller | Contact this seller

Buy New
72.33
Convert currency

Add to Basket

Shipping: 5
From United Kingdom to U.S.A.
Destination, rates & speeds

4.

Tobin
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 2
Seller:
firstbookstore
(New Delhi, India)

Book Description Condition: Brand New. Brand New Original US Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Seller Inventory # ABOCT-52531

More information about this seller | Contact this seller

Buy New
94.82
Convert currency

Add to Basket

Shipping: FREE
From India to U.S.A.
Destination, rates & speeds

5.

Tobin
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 5
Seller:
Bookshub
(Karol Bagh, India)

Book Description Condition: New. New. US edition. Perfect condition. Customer satisfaction our priority. Seller Inventory # ABE-SEP-113092

More information about this seller | Contact this seller

Buy New
95.30
Convert currency

Add to Basket

Shipping: FREE
From India to U.S.A.
Destination, rates & speeds

6.

Tobin
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 5
Seller:
EBOOKSTORE2010
(New Delhi, ND, India)

Book Description Condition: Brand New. New. US edition. Customer Satisfaction guaranteed!!. Seller Inventory # SHUB113092

More information about this seller | Contact this seller

Buy New
95.33
Convert currency

Add to Basket

Shipping: FREE
From India to U.S.A.
Destination, rates & speeds

7.

John J. Tobin, Gary Walsh
Published by Wiley-Blackwell (2008)
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Hardcover Quantity Available: 1
Seller:
Ergodebooks
(RICHMOND, TX, U.S.A.)

Book Description Wiley-Blackwell, 2008. Hardcover. Condition: New. 1. Seller Inventory # DADAX3527318771

More information about this seller | Contact this seller

Buy New
97.40
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

8.

Tobin
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 2
Seller:
Romtrade Corp.
(STERLING HEIGHTS, MI, U.S.A.)

Book Description Condition: New. Brand New Original US Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship fro the US or other locations in India depending on your location and availability. Seller Inventory # AUOCT-52531

More information about this seller | Contact this seller

Buy New
99.12
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

9.

Tobin
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Quantity Available: 5
Seller:
Basi6 International
(Irving, TX, U.S.A.)

Book Description Condition: Brand New. New. US edition. Excellent Customer Service. Seller Inventory # ABEUSASEP19-113092

More information about this seller | Contact this seller

Buy New
101.35
Convert currency

Add to Basket

Shipping: FREE
Within U.S.A.
Destination, rates & speeds

10.

Tobin, John J./ Walsh, Gary
Published by Vch Verlagsgesellschaft Mbh (2008)
ISBN 10: 3527318771 ISBN 13: 9783527318773
New Hardcover Quantity Available: 2
Seller:
Revaluation Books
(Exeter, United Kingdom)

Book Description Vch Verlagsgesellschaft Mbh, 2008. Hardcover. Condition: Brand New. new edition. 260 pages. 9.50x6.75x0.75 inches. In Stock. Seller Inventory # __3527318771

More information about this seller | Contact this seller

Buy New
100.49
Convert currency

Add to Basket

Shipping: 7.50
From United Kingdom to U.S.A.
Destination, rates & speeds

There are more copies of this book

View all search results for this book