首页 >
法律 >
医疗法 >
Guide To EU Pharmaceutical Regulatory Law, 8th Edition

Guide To EU Pharmaceutical Regulatory Law, 8th Edition

作者： Sally Shorthose
出版商： Kluwer Law International
ISBN: 9789403530253
出版时间 January 2023
规格： Hardback , 832 pages
适应领域： European Union ? 免责申明：
Countri(es) stated herein are used as reference only

List Price: ￥2,280.00

￥2,211.60 Save ￥68.40 (3%)

或

下载订单表

加入收藏
| 加入比较

描述
大纲

详细
About this book:

Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe.

What’s in this book:

Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe, each of the following twenty-one incisive chapters, examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered are the following:
- clinical trials;
- stages and standards for creating a product dossier;
- obtaining a marketing authorisation;
- how and when an abridged marketing authorisation procedure can be used;
- criteria for conditional marketing authorisations;
- generic products and ‘essential similarity’;
- paediatric use and the requisite additional trials;
- orphan medicinal products;
- biologicals and ‘biosimilars’;
- homeopathic, herbal and similar medicines;
- medical devices;
- pandemics, epidemics and vaccines;
- pharmacovigilance;
- parallel trade;
- advertising; and
- relevant competition law, intellectual property rights and data protection regulation.
In addition, at the end of each chapter, a list of guidelines/publications has been included that will direct the readers to sources of additional information.

How this will help you:

Dealing primarily with the European level of legislation, the book offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations. This distinctive book will be of high relevance to pharmaceutical lawyers and regulatory advisers, both in-house and in private practice.
About the Editor and Authors

Foreword

List of Abbreviations

Brexit

CHAPTER 1 Overview of European Pharmaceutical Regulatory Requirements

Sally Shorthose

CHAPTER 2 Overview of Intellectual Property Rights

Sally Shorthose & Tasmina Goraya

CHAPTER 3 Clinical Trials

Sally Shorthose

CHAPTER 4 Obtaining a Marketing Authorisation

Sally Shorthose & Sarah Faircliffe

CHAPTER 5 Conditional Marketing Authorisations

Sally Shorthose

CHAPTER 6 Supplementary Protection Certificates

Tasmina Goraya

CHAPTER 7 Paediatrics

Sally Shorthose & Sarah Faircliffe

CHAPTER 8 Advertising Medicinal Products for Human Use

Anne-Charlotte Le Bihan, Jean-Baptiste Thiénot, Sally Shorthose, Sarah Faircliffe, Marc Martens, Nicolas Carbonnelle, Ulf Grundmann, Hanneke Later-Nijland, Mauro Turrini, Gabriel Lidman & Raquel Ballesteros

CHAPTER 9 Pharmacovigilance

Sally Shorthose

CHAPTER 10 Variations to Marketing Authorisations

Tasmina Goraya

CHAPTER 11 Combination Products

Sarah Faircliffe

CHAPTER 12 Abridged Procedure

Hanneke Later-Nijland

CHAPTER 13 Orphan Drugs

Sarah Faircliffe

CHAPTER 14 Biopharmaceuticals

Marc Martens & Nicolas Carbonnelle

CHAPTER 15 Homeopathic, Herbal, and Traditional Herbal Medicinal Products

Hanneke Later-Nijland

CHAPTER 16 Advanced Therapy Medicinal Products

Marc Martens & Nicolas Carbonnelle

CHAPTER 17 Vaccines

Raquel Ballesteros

CHAPTER 18 Medical Devices

Ulf Grundmann, Alexander Csaki, Clarissa Junge-Gierse & David Janiszewski

CHAPTER 19 Parallel Trade

Hanneke Later-Nijland

CHAPTER 20 Competition Law in the Pharmaceutical Sector

José Rivas & Silvia Pronk

Appendix Guidelines and Publications

Table of Cases

Directives

Other Legislation

Regulations

Index

你可能需要


The Hong Kong Company Secretary's Handbook: Practice and Procedure (11th Edition): List Price: ￥508.25

￥493.00 Save ￥15.25 (3%)


Hong Kong Tax & Accounting Practical Toolkit (Basic Package): ￥3,229.05


Hong Kong Company Secretary Checklist, 2nd Edition: List Price: ￥1,311.00

￥1,271.67 Save ￥39.33 (3%)


Law of Companies in Hong Kong, 4th Edition (Hardcopy + e-Book): List Price: ￥3,325.00

￥3,225.25 Save ￥99.75 (3%)


Butterworths Hong Kong Discrimination Law Handbook, 4th Edition: List Price: ￥1,425.00

￥1,282.50 Save ￥142.50 (10%)


Sentencing in Hong Kong, 11th Edition: List Price: ￥3,401.00

￥3,060.90 Save ￥340.10 (10%)


Butterworths Hong Kong Company Law (Winding-Up and Miscellaneous Provisions) Handbook, 6th Edition: List Price: ￥2,166.00

￥1,949.40 Save ￥216.60 (10%)


Butterworths Hong Kong Company Law Handbook, 26th Edition: List Price: ￥4,180.00

￥3,762.00 Save ￥418.00 (10%)


Cross-Border Crime in Hong Kong: Extradition, Mutual Assistance & Financial Sanctions, 3rd Edition: List Price: ￥1,976.00

￥1,916.72 Save ￥59.28 (3%)


Clough & Clough on Personal Injuries: List Price: ￥1,425.00

￥1,382.25 Save ￥42.75 (3%)


Hong Kong Personal Insolvency Manual, 3rd Edition: List Price: ￥1,900.00

￥1,843.00 Save ￥57.00 (3%)


Butterworths Hong Kong Conveyancing and Property Law Handbook, 6th Edition: List Price: ￥1,710.00

￥1,658.70 Save ￥51.30 (3%)


A Practical Guide to Resolving Shareholder Disputes, 2nd Edition: List Price: ￥1,710.00

￥1,658.70 Save ￥51.30 (3%)


Tort Law in Hong Kong, 5th Edition (Hardcopy + ebook): List Price: ￥2,375.00

￥2,303.75 Save ￥71.25 (3%)


Company Law in Hong Kong: Practice and Procedure 2023 (Hardcopy + e-Book): List Price: ￥3,038.10

￥2,946.96 Save ￥91.14 (3%)


Company Law in Hong Kong: Insolvency 2023 (Hardcopy + e-Book): List Price: ￥2,700.85

￥2,619.82 Save ￥81.03 (3%)


Hong Kong Company Law, 15th Edition: List Price: ￥467.40

￥453.38 Save ￥14.02 (3%)


Private Equity in Hong Kong and China, 4th Edition: List Price: ￥1,900.00

￥1,843.00 Save ￥57.00 (3%)


Butterworths Hong Kong Company Law Handbook, 25th Edition: List Price: ￥4,275.00

￥4,146.75 Save ￥128.25 (3%)


Hong Kong Family Court Practice, 4th Edition: List Price: ￥2,565.00

￥2,488.05 Save ￥76.95 (3%)

“

Ordering from Professional Bookshop is fantastic, quick delivery great products, great customer service Siti L.
This is a great bookstore and have had no problems with them and all my orders have come on time and in good condition. Yang X.
Everything is perfect. Fast delivery. I highly recommend this website to all my friends and colleagues. Thanks Hoi Man L.
So thankful I am receiving all my books, thank you to all for a great service and excellent products Clinton K.
Professional Bookshop is amazing! I've been a loyal customer for over 5 years. Returns are easy to request, book or delivery complaints are taken seriously and the customer service team is friendly and patient. Mick D.
I wanted to informed you that the customer service is excellent. They were so polite and nice. I would continue to buy books from Professional Bookshop. Jingsong C.
Fast and quick service. Easy transaction method, arrived sooner than expected. Excellent packaging and the books received are in perfect condition! Thank you very much! I love the book and its quality. Saori B.
I can order any accounting books from worldwide from Professional Bookshop. Love this website and save my time to search from internet. Lingxiao R.
It is just so easy to find what you are always looking for and sometimes you can even find it up to 80% off what you would in the normal store. Graeme R.
I love shopping on Professional Bookshop! They have a wide range of accounting book with competent prices. Free shipping in Hong Kong is also really handy! Fergus Y.
Professional Bookshop is a great bookstore, I must say. Buying books in Professional Bookshop is so easy, great and reliable. It is highly recommendable. Deborah D.
A great site to shop accounting books and everything and with discountable prices. It’s my first choice whenever i want to shop something. Most trusted site. Zeng Z.
I found the books I needed and at a very low price. I am very happy and will definitely use it in the future Brian W.
I have been using Professional Bookshop for a while now. I am very impressed with customer service and delivery. When I need to have a return it is done very diligently. Olivia L.
Professional Bookshop is my default go to for finding the best prices and reading details of law books before buying. Detailed book description is very helpful. Tracy W.
I've been using Professional Bookshop since 2011 and they actually great, I always received great service and my book arrives on time. Lisa C.

所有书籍

Guide To EU Pharmaceutical Regulatory Law, 8th Edition

Free delivery Hong Kong?

详细

你可能需要

What Our Customers Say?

所有书籍

Guide To EU Pharmaceutical Regulatory Law, 8th Edition

Free delivery Hong Kong?

详细

你可能需要

What Our Customers Say?

video title