Regulatory Affairs

Regulatory Affairs White Papers

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46-55 of 55 results
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
46-55 of 55 results