Improving the Regulatory Review Process: Assessing Performance and Setting Targets
Language: English
Published by Kluwer Academic Publishers, 1998
- Hardcover
- Used
Seller: Fireside Bookshop, Stroud, GLOS, United KingdomFireside Bookshop
AbeBooks seller since September 22, 2000
Association member: PBFA
Condition: Used - Very good
£ 20.00
Quantity: 1 available
Add to basketItem description from seller
Type: Book At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory authorities are concentrating on improving their efficiency and effectiveness. Therefore, it is not surprising that questions are being asked as to how performance might be measured and compared between different authorities who are now often in receipt of dossiers that have been submitted to several agencies at the same time. Issues such as "what target should be set for the review of new medicines?" and "how can quality be assured?" are now considered to be of critical importance. The 12th CMR International Workshop, held in January 1997, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss experiences and exchange views on how to improve the review process. The proceedings of this meeting provide a comprehensive overview of the current review process in different countries and the need for performance measures and targets. This volume summarizes the many suggestions that were debated at the workshop, and includes chapters on measuring performance, and on the integration of quality into the review process. 163pp.…
Seller Inventory # 015178
- Title
- Improving the Regulatory Review Process: Assessing Performance and Setting Targets
- Author
- Edited By McAuslane,Neil and Walker,Stuart
- Publisher
- Kluwer Academic Publishers
- Publication year
- 1998
- Condition
- Very Good
- Dust jacket
- No d/j as Published
- Binding
- Cloth/Laminated Boards
- Language
- English
- ISBN 10
- 0792387317
- ISBN 13
- 9780792387312
- Item weight
- 14 ounces
- Dimensions
- 8vo - over 7¾" - 9¾" tall
- Seller catalogs
- MEDICINE
"Synopsis" may belong to another edition of this title.
Fireside Bookshop
Stroud, GLOS, United Kingdom
Shipping rates from United Kingdom to U.S.A.
| Item | 6 to 14 business days | 5 to 14 business days |
|---|---|---|
| First item | £ 25.00 | £ 27.50 |
Payment methods
Store description
The Fireside Bookshop has now moved to Stroud in Gloucestershire.Our opening hours are from 10a.m.-5p.m. Tuesday to Saturday. Click on the Fireside Bookshop name above for more contact information.
Specialty
Art, Modern First Editions, Mathematics, Science, Social History, Religion, Architecture, Occult, Humanities, HistoryAssociation member
Seller's business information
Fireside Bookshop
United Kingdom
Terms of sale
Books are despatched the same day as the order is confirmed.We are very happy to
answer any other enquiries regarding our stock either by E mail or phone.
Rob Sheppard.Fireside Bookshop.8 Rowcroft, Stroud, Gloucestershire, GL5 3AZ
info@firesidebookshop.co.uk 01453 764500
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to Fireside Bookshop, Stroud, United Kingdom, +44 01453764500, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Postage costs are based on books weighing 2.2 LB, or 1 KG. If your book order is heavy or oversized, we may contact you to let you know extra postage is required.
Any queries please email us or phone +44(0)1453 764500