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Artwork Matters

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Andrew Love
In my last article I talked about the need to be responsive to an evolving picture both when selecting your implementation partners but also when working out what is going to be the best solution for meeting the serialisation requirements and including the make-up of your project team. In this next article, covering tips 6, 7 and 8, I talk about Read more
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June 21, 2016 by Andrew Love
Andrew Love
In the last article I looked at the starting point of developing your organisation’s strategy, the legislation and its impact. In this article I discuss defining your solution, what to look for when picking your implementation partners and the key aspects to consider when resourcing the project team.
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May 16, 2016 by Andrew Love
Andrew Love
Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well organised and clear.
Tags: Andrew Love | andrew | love | translation | provider | translate | Document | packaging | regulation | compliance
October 5, 2015 by Andrew Love
Andrew Love
As we continue in this series of articles expanding on Ensuring Effective Translations to help you establish your translation capability, the next set of tips are based around step 2 – Initiate your project.
Tags: translations | Effective Translations | translation capability | Andrew Love | translation quality plan
May 6, 2015 by Andrew Love

Making Tomorrow's Medicines

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Tony Hitchcock
Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and Read more
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May 10, 2016 by Tony Hitchcock

Market Access, Trends and Outlook

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Regina Au
In this Pharma IQ interview, Regina Au from BioMarketing Insight shares her insights on the current UDIs for medical devices landscape and the impact of the FDA’s final rule on UDIs on the medical device industry, both in the US and on a global scale. Au also reveals the 5 key business benefits for medical device manufacturers.
Tags: UDIs | UDI | Unique Device Identification for Medical Devices | REgina Au | medical device UDIs
July 4, 2015 by Regina Au

Pharma Cyber-Karma

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Mollie Shields-Uehling
When it comes to greater efficiencies and cost savings in filing electronic submissions, the European Medicines Agency is well ahead of any other regulatory agency on the planet. They're on record stating... The Agency expects the exchange of digitally signed electronic documents to increase the efficiency of procedures and Read more
Tags: Mollie Shields-Uehling | global regulatory leadership | European Medicines Agency | electronic documents | digitally signed electronic documents | Digital Signatures
September 28, 2014 by Mollie Shields-Uehling

Ensuring a Change for the Better

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Cristina Falcão
Today’s Supply chain companies demand a near perfect order record to reduce the cost of labor, transportation and errors within their distribution centers. We interviewed Tom Napier from PSI Engineering, which provides tailored products to the pharma industry.Their systems not only reduce costs, but also helpfight counterfeiting and secure the Read more
Tags: Cristina Falcão | Tom Napier | PSI Engineering | droug counterfeiting | counterfeiting | supply chain | document automation
August 28, 2012 by Cristina Falcão
Cristina Falcão
Marketing exclusivity in EU and U.S.A provided a monopolistic market for orphan drugs without “me-too”/generics competitors, to pharma companies.| Orphan drug laws and the pharma industry made great contributions towards the cure of millions of people offering from uncommon and frequently life-threatening diseases. However, it is necessary to Read more
Tags: orphan drugs | orphan drug market | personalised medicine | orphan drug laws | Cristina Falcão
October 19, 2011 by Cristina Falcão
Cristina Falcão
Pharmaceutical companies are facing times of unprecedented challenge; expiring patents, generics competition, clogged pipelines, pricing pressures, huge R&D costs, all contribute to major revenue losses. Is outsourcing the “pain killer” for this highly regulated industry? What are the biggest challenges in pharmaceutical outsourcing?
Tags: Cristina Falcão | pharmaceutical outsourcing | pharmaceutical outsourcing challenges | outsourced services | CRO | CMO | due-diligence | outsourcing clinical trials
May 16, 2011 by Cristina Falcão
Cristina Falcão
The world’s most highly regulated industry seems doomed to “forward retreat” tiptoeing into social media. Why? The reason lies on social media’s gist - user generated content (UGC) is the raison d'être but also the main drawback, since the lack of rules on the accuracy of online content (written by the users of websites such Read more
Tags: Cristina Falcao | Social Media | social media regulations | social media in pharma | facebook | twitter | LinkedIn | European Directive 2001/83 | adverse events reporting | AER | patient recruitment | Clinical Trials | blogs | PMCPA | EFPIA -guidelines
April 18, 2011 by Cristina Falcão

Pharma Patents

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Alpesh Pathak
To determine whether the patentee has right to exclude for a particular claimed invention, it is essential to know what is claimed and this process is called determining the scope of the invention or claims construction.
Tags: Alpesh Pathak | Alembic Pharmaceuticals | patent cell | patents | claim construction | patent infringement litigation | pharma IP | pharma patents | claims construction | IP | intellectual property | patenting crystalline forms | IP strategies crystalline forms
July 14, 2011 by Alpesh Pathak

Drug Safety – Please Read the Insert!

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Elie Magdalani
As an important arm for pharmacovigilance, recently many voices are raised to consider using clinical trials in the post-marketing surveillance phase and not only depending on non-clinical or experimental methods to study drug safety issues after marketing the drug.
Tags: Elie Magdalani | pharmacoepidemiology | pharmacovigilance | epidemiology | drug safety | clinical pharmacology | adverse drug reactions | Adverse Drug Reaction | ADRs | Adverse Event | AE | pharmacovigilance activity
July 3, 2011 by Elie Magdalani
Elie Magdalani
We can not separate pharmacovigilance from medication errors, pharmacovigilance had always been concerned with minimizing the risks of adverse drug reactions and medication errors. Pharmacovigilance contributes to the detection and prevention of medication errors, collaboration of all parties will improve the quality of data collected, and Read more
Tags: Elie Magdalani | Ranbaxy Egypt | medication errors | ME | pharmacovigilance | detection medication errors | prevention medication errors | pharmacovigilance ADRs | patient safety | drug safety | error analysis | drug labeling and packaging
June 2, 2011 by Elie Magdalani
Elie Magdalani
The role of pharmaceutical companies is to decide how to manage the results of an AE signal. Some drug companies develop and prepare the safety programs that are implemented from the moment drugs when enter their product portfolio. Also collecting and analysing data in an advance way is an important tool in drug safety and risk management program Read more
Tags: Elie Magdalani | Ranbaxy Egypt | pharmacovigilance | drug safety | Risk Management | global drug safety | reported adverse events | AEs | adverse events | ADR | risk assessment | signal detection | AE signal
May 5, 2011 by Elie Magdalani
Elie Magdalani
Emerging new safety data may result in an action plan by the pharmaceutical company producing a drug to review its data retrieved during the clinical trail phases and especially in Phase II conducted to demonstrate and assess the product’s safety.
Tags: Elie Magdalani | Ranbaxy Egypt | pharmacovigilance | Clinical Trials | drug safety | AE | ADRs | post-marketing surveillance
February 3, 2011 by Elie Magdalani