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Regulatory Affairs White Papers

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31-45 of 45 results
Combination Products Workshop, 17th October 2013, Basel, Switzerland
| By Drug Information Association
This one-day workshop will provide delegates with an understanding of the current regulatory framework for drug/device combinations and companion diagnostics, and of the anticipated impact of the revision of the European medical device and In-Vitro Diagnostics (IVD) legislation.
Regulatory Affairs > White Papers
14th DIA Conference on European Electronic Document Management (eDM) 20–22 November 2013 Dublin, Ireland
| By Drug Information Association
During the middle ages alchemists were looking for the Philosopher’s Stone. As it was believed, the mythical substance could not only turn lead into gold, but also prolong life and restore youth. Although the goal was never achieved, alchemy paved the way to scientific methods and so to the medical advances of today. This has transformed our lives in more than one way.
Regulatory Affairs > White Papers
7th DIA/EFGCP/EMA Medicines for Children Conference, 24th-25th September 2013, London, UK
| By Drug Information Association
This year’s DIA/EFGCP/EMA paediatric conference will take place in the seventh year of the EU Paediatric Regulation. Over 1’000 Paediatric Investigation Plans (PIPs) have been submitted so far and paediatric aspects are now an integrated part of drug development.
Regulatory Affairs > White Papers
Joint DIA/MHRA Statistics Workshop 2nd-4th October 2013, London, United Kingdom
| By Drug Information Association
Life-cycle management is a widely accepted concept for the development and marketing of medicines. At each step of this process, pre- and post-licensing, statisticians work to develop methods that can improve efficiency and can enhance decision-making through optimal study design, analysis and inference. The workshop aims to discuss the latest developments in statistical methodology and decision-making in exploratory development, confirmatory development, licensing decisions and management of benefits and risks post-licensing.
Regulatory Affairs > White Papers
7th Annual DIA Clinical Forum Dublin, Ireland on 8–9 October 2013.
| By Drug Information Association
The DIA Clinical Forum is known as a conference that brings together experts from different fields, including data management, clinical operations, drug safety, medical affairs, medical information and medical writing. Experts share their expertise and experience with people from other companies and disciplines. Making the presentations and workshops relevant to the day to day work of participants has always been the focus of previous programme committees – and I am glad to confirm that this won’t be any different this year.
Regulatory Affairs > White Papers
10th Middle East Regulatory Conference (MERC) 2013. Collaboration, Partnership and Interaction: Authority and Industry
| By Drug Information Association
This is the 10th DIA Middle East Regulatory Conference in partnership with the Middle East Regulatory Network (MERN). The MERN is an ad hoc regional network of the EFPIA (European Federation of Pharmaceutical Industries and Associations). The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to have access to good quality medicines, including innovative medicines.
Regulatory Affairs > White Papers
26th Annual EuroMeeting Vienna 2014, 25th - 27th March 2014 ACV, Vienna, Austria
| By Drug Information Association
The Annual EuroMeeting is DIA’s largest conference in Europe, attracting more than 3,000 professionals from industry, government, academia, as well as patient groups and students. It is unique in the quality of its content and speakers, and in the opportunity to network with like minded professionals, regulators and thought leaders. Early-bird rate for DIA Members – register by Tuesday, 11 February 2014 and save €185! Register onsite at DIA 2013 to save an additional €100!
Regulatory Affairs > White Papers
Quality by Design: Manufacturing at a Comprehensive GMP-Level
| By 3R Pharma Consulting
This whitepaper is Dr. Manuel Zahn’s presentation, 'Quality by Design'. This was delivered at the ,VISION PHARMA 2013, trade fair in Karlsruhe, Germany. 3R Pharma were present for the duration of the trade fair.
Regulatory Affairs > White Papers
Farfield Analight 4D Workstation
| By Farfield Group
Supremely sensitive, the Farfield Ana Light® quantifies real-time protein conformational changes and membrane structure, to reveal the mechanisms underpinning biomolecular interactions.
Regulatory Affairs > White Papers
Product Brochure
| By Farfield Group
Download our full product brochure here.
Regulatory Affairs > White Papers
Global Compliance for Medical Device Industry: Who needs Compliance to CFR, ISO13485, JPAL, D-MAH or 9100?
| By ENNOV
Medical device companies of all sizes face real challenges from emerging markets and international compliance. Many of the worlds regions are going through transformations where countries are making decisions to control their own destiny with respect to the standards and the requirements for regulatory compliance. Going, going, going gone are the days when other countries will accept the US standards and policies for managing the compliance or RAQA requirements.
Regulatory Affairs > White Papers
International Product Law Manual
| By Jardine Lloyd Thompson Limited
Jardine Lloyd Thompson Limited (JLT) was delighted to contribute to the recently published 'International Product Law Manual' by Kluwer Law International.
In addition to examining the current insurance environment for life science companies, this chapter will review the recent history of life science insurance and explain how we have got to where we are. It then identifies some of the main players, reviews the procurement process, identifies some typical policy wordings, and gives examples of how coverage can be impacted if attention to detail is not paid. The chapter then explores how claims are managed and set out practical issues to be aware of. Finally, the chapter explores recent developments that might influence the future of product liability insurance for life science companies.
*Arundel McDougall & Prashant Popat (eds), International Product Law Manual (copyright Kluwer Law International, 2010)

Regulatory Affairs > White Papers
Life Science and Chemistry Group
| By Luzzatto & Luzzatto
The role of intellectual property in the life sciences and chemical industries cannot be overestimated. Companies developing pharmaceuticals and drugs invest huge R&D resources long before they are able to prove the effectiveness of a new product and obtain regulatory approval. However the resulting products offer the potential for spectacular returns.
Regulatory Affairs > White Papers
Luzzatto & Luzzatto Company Brochure
| By Luzzatto & Luzzatto
Luzzatto & Luzzatto actively engages in all aspects of patent work, both for domestic and for foreign clients. Patent drafting, prosecution, opinions and patent and literature searches are the firm's everyday work. L&L's R&D-oriented technical staff deals with different disciplines, with particular emphasis on biotechnology, pharmaceutical and industrial chemistry, electronics, software, computer processes and mechanics, to provide a wide range of technical services and assistance.
Regulatory Affairs > White Papers
Trademark Department
| By Luzzatto & Luzzatto
Luzzatto & Luzzatto's Trademark Department comprises a leading group of lawyers who are broadly acknowledged for their IP capabilities. Our professionals possess deep knowledge and experience in developing strategy to secure, protect and enhance the IP value of the firm's clients and to suit their specific business objectives.
Regulatory Affairs > White Papers
31-45 of 45 results