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PUBLICATIONS

Pharmaceutical Manufacturing and Packing Sourcer

pmps
Spring 2017

   
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Industry Insight 
Industry Insight

Robert Harris
, PMPS Industry Advisor, highlights the importance of patient-centricity and picks out key articles from this issue that address this topic.
 
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Drug Delivery 
mHealth and Smart Technology

Breathing New Life into Asthma Care

Ali Moiyed
at Aerobit Health uncovers how connected devices could enhance patient compliance. With a particular focus on inhalers, he argues that this could be one way in which the pharma industry can keep up with advances in technology.
 
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Optimising Inhalation Therapy

Partial to Particles


Breath-actuated mechanisms are becoming increasingly common in inhalation devices due to their beneficial impact on fine particle doses. Dr David Lewis, Alan Tweedie and Francesca Mason at Chiesi investigate their potential.
 
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Anti-Counterfeiting
The Falsified Medicines Directive

Is Europe Ready?


As the Falsified Medicines Directive deadline looms ever closer, Christoph Krähenbühl at 3C Excellis Europe clarifies what everyone, from manufacturers to wholesalers and pharmacists, need to do to ensure that the continent is prepared.
 
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Validation & Compliance
Electronic Batch Records

Paper Chase

COPA-DATA’s Robert Harrison
argues for the transition from paper-based documentation to digitised production records in a bid to improve regulatory compliance and the management of data.
 
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SUPPLY CHAIN MANAGEMENT & LOGISTICS
Outsourcing Supply Chains

Branching Out


Developing robust supply chains while simultaneously reducing expenditure and meeting global compliance can be challenging. Henry Moran and Amy Shortman of ASC Associates share their thoughts on why turning to outsourcing could be the answer.
 
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Anti-Counterfeiting Measures

Security Breach


As a result of increased globalisation, pharma firms are constantly being put under greater pressure to provide a secure end-to-end supply chain. Although a daunting challenge, Pinkerton’s Steve Ward explains how this can be achieved to ensure drug safety and mitigate the risk of large economic losses.
 
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Innovative Supply Chains

New Thinking

Jan Denecker
at UPS Europe discusses the significance of flexibility in the supply chain as a result of today’s shift towards increasingly complex drugs. Manufacturers and third-party logistics providers must be ready to work together to create the efficiency needed.
 
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PACKING & PACKAGING
Advancing Patient Protection

Easy Access

Amcor’s Colin Reed
and Greg Rosati investigate the vital role that packaging plays in compliance. Often seen as an inconvenient part of the supply chain, they uncover why it should be treated as more than simply fulfilling a regulatory need.
 
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Child-Resistant Packaging

Open and Close


In order to develop child-resistant packaging that is also easy to use for the elderly, continuous testing is key. Stephen Wilkins at Davies Development and Testing sheds some light on the complications with regards to staying compliant.
 
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Packaging Design

First Impression


Conveying important information to patients through packaging and labelling is an arduous task in the pharma industry. Essentra’s Alan Davies explains why getting it right is so important in terms of design and compliance.
 
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Patient-Centred Design

Packaging for People


Dr Karel van der Waarde
at Graphic Design-Research elucidates why it is necessary to consider the end user as well as legal and economic packaging requirements so that medicines can be handled safely, correctly and efficiently.
 
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PREVIEWS & REVIEWS
Event Preview

Join the Crowd


Valerio Del Vecchio at the PPMA Group presents an enticing look at the upcoming PPMA Show and why Birmingham is the place to be this September.
 
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the end of the line
End of the Line

Manufacturing a Renaissance


Pharma keeps on innovating, but PMPS Industry Advisor Robert Harris asks if this is enough for the sector to stay on par with other areas.
 
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CLINICAL TRIAL SUPPLIES & LOGISTICS
Clinical Supply Challenges

Under Control


The manufacture and distribution of controlled drugs is tightly governed, but regulations vary around the world and tend to cause a considerable amount of complexity. PCI Clinical Services’ Rich Nelson explores why experienced supply partners are vital in this field.
 
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Clinical Trial Supply

Supply and Demand

SIRO Clinpharm’s Partha Chatterjee
investigates the importance of collaboration between clinical operations and clinical trial supply teams in order to achieve more effective and efficient studies.
 
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August, and November

News and Press Releases

Nemeras preservative-free multidose eye dropper Novelia® approved for Santens Cosopt® for Glaucoma treatments in 29 European countries

Nemera is pleased to announce that its multidose eye dropper Novelia® has been approved for the preservative-free formulation Cosopt iMulti® (20mg/ml dorzolamide + 5mg/ml timolol eye drops, solution).
More info >>

White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

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