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Contributor: Kevin Gillespie
Posted: 02/21/2012 12:00:00 AM EST
With more and more companies going paperless- many of whom are now moving toward LIMS and ELN selection and implementation-your industry may be facing subsequent issues of interoperability between systems, which systems work best, knowledgeable staff, regulatory oversight, cost and more. In this interview, Kevin Gillespie, Manager, Laboratory Information Systems, Momenta Pharmaceuticals, shares his do's and don'ts for strategic planning of laboratory informatics. Read more Contributor: René Holm
Posted: 02/09/2012 12:00:00 AM EST
With the advent of improved techniques for drug discovery, there has been a transition towards new chemical entities to be hydrophobic and non-polar, which in turn has made solubilization of these entities difficult. Lipid formulations can provide effective solubilization in the dosage form and in vivo. Pharma IQ interviewed René Holm, PhD, Head of Preformulation, H. Lundbeck A/S to learn more: Read more Contributor: Brett Cooper
Posted: 01/19/2012 12:00:00 AM EST
As the demand for quality and efficiency intensifies year on year the need for measures such as PAT and QbD becomes more prominent. The constantly evolving landscape of the PAT and QbD industry sees an increased regulatory pressure to adopt these quality practices in line with producing high quality drug products at all times. Read more Contributor: Hassan Bibi
Posted: 01/19/2012 12:00:00 AM EST
"For me the regulatory approval is a matter of technical, physical, scientific approach that we should really have aligned together, definitely the importance of the product, the need of the product in the market," said Hassan Bibi, Regional Regulatory Affairs Director NEWAAT - Janssen Pharmaceutical companies of Johnson and Johnson. Read more Contributor: Dan Holst Jakobsen & Abhijit Bendre
Posted: 01/19/2012 12:00:00 AM EST
Dan Holst Jakobsen, Systems Specialist & IT Coordinator and Abhijit Bendre Business Analyst CMC Clinical Supplies from Novo Nordisk, discuss how to reduce risk through packaging and the many operating challenges related to clinical trial supply of temperature sensitive IMPs and materials. Read more Contributor: Christian Borel
Posted: 12/20/2011 12:00:00 AM EST
In this quickfire Q&A Dr. Christian Borel, Director Sales & Operations Planning Process, Supply Chain Department, Ares Trading S.A, An affiliate of Merck Serono S.A., speaks to Pharma IQ about the 3 main challenges with regards to improving supply chain integration and critical success factors for S&OP. Read more Contributor: Jack Wong
Posted: 12/20/2011 12:00:00 AM EST
"Regulations keep on changing, in particular in all the established countries like China and Japan. Another change is that many countries don’t have regulations at the moment but they are going to have new regulations coming, so they will uniquely register in their country very soon," said Professor Jack Wong, Director, Regulatory Affairs, Johnson and Johnson Medical. Read more Contributor: Wang Tao
Posted: 12/15/2011 12:00:00 AM EST
With more clinical trials being held in China than ever before, clinical trial supply systems need to become increasingly sophisticated in order to cope with local regulations, importation and exportation guidelines, application of licenses, transit, packaging and labeling requirements, temperature-controlled storage and transportation and local distribution. In this quickfire Q&A we speak with Wang Tao, Head of Clinical Operations at Genzyme. Read more Contributor: Hans-Georg Eichler
Posted: 11/25/2011 12:00:00 AM EST
"It is important for all stakeholders - patients, but also industry - that we share a common view of the merits and the value of a drug. When I say value, I do not mean financial value because we as regulators don’t look at economics and financial value," said Hans-Georg Eichler, Senior Medical Officer, EMA. Read more Contributor: Viliam Kovac
Posted: 11/23/2011 12:00:00 AM EST
Viliam Kovac, Vice President Global Supply Chain Quality, Roche, speaks to Pharma IQ about reducing supply chain vulnerabilities across the global pharmaceutical supply chain, improving distribution operations across the Middle East and implementing an effective risk management strategy into the supply chain. Read more Contributor: Mohamed Nasser
Posted: 11/17/2011 12:00:00 AM EST
So it looks to me like many of the future products are going to be somehow covered by a cold supply chain, or a need for a cold supply chain. Read more
87 interview results Advertisement
Events of Interest-
2nd Annual Bio/Pharmaceutical Cold Chain China 2012
Renaissance Beijing Capital Hotel, Beijing, China
February 28- 29, 2012 -
10th Annual Cold Chain Management & Temperature Control Summit - Canada
Hyatt Regency, Toronto, Canada
February 27- 1, 2012 -
Cold Chain Global Forum 2012
September 17- 21, 2012 -
2nd Annual Pharma Regulatory Affairs Asia
Amara Singapore Hotel, Singapore
April 25- 26, 2012
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