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Pharmaceutical Manufacturing and Packing Sourcer

Industry Insight

It goes without saying that, if medication is not delivered correctly, it will be ineffective. With asthma and Chronic Obstructive Pulmonary Disease on the rise, ensuring patients get their medicine exactly as prescribed is imperative. Sam Van Alstyne at 3M Drug Delivery Systems focusses on the technology that could make adherence easier, thereby solving this growing urgency (page 44). Meeting patient priorities and combining it with an interactive smartphone device can help the doctor-patient relationship and benefit the patient and the payers in long-term gains.

We are a global society, with shipments, clinical trials, and every aspect of the supply chain set up to make sure the patient receives the right drug at the right time. Sharon Courtney at Almac Group can help you strategise for the process that includes the country-specific requirements (page 20). This can affect duties, taxes, and your bottom line. To lower costs by conducting a trial in India, for example, getting the paperwork right is key to success it is all about making the unpredictable predictable.

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News and Press Releases

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

Cell Therapy Manufacturing & Gene Therapy Congress

4-6 December 2018, RAI, Amsterdam

Bringing together 300+ leaders and key influencers from pharma and biotech companies on 4 - 6 December 2018 in Amsterdam, Cell Therapy Manufacturing & Gene Therapy will provide you with the latest advice for transforming innovative research to prosperous cell & gene therapy manufacturing.
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