spacer
home > ebr > summer 2017 > organisation optimisation
PUBLICATIONS
European Biopharmaceutical Review

Organisation Optimisation

Mature products are often still sold in substantial numbers with a widespread global footprint, despite being long past their marketing exclusivity. They are critical to an organisation’s growth and revenue, alongside the development of new ones. Since they have been on the market for a while, they open up the possibility for marketing authorisation holders (MAHs) to manage processes in a more efficient and cost-effective manner – allowing them to consider an integrated safety, regulatory and benefit-risk model.

Their Importance


While at the end of their lifecycle, mature products are still likely to be sold well into the future and have a crucial role in the healthcare industry across different markets. Their proven effectiveness and safety profiles make them particularly significant in emerging markets where they can be introduced, manufactured and distributed more quickly. Since the cost of maintenance is substantially lower than that of a new product, pharmaceutical companies can focus on tailoring them to individual market needs, which is usually done through formula innovation, changing the dosage form or altering the packaging.

A blockbuster drug passing its patent exclusivity has a significant financial impact for the manufacturer. As generics enter the market, most firms have to re-evaluate the cost spent on product maintenance and minimise expenditure in order to sustain their profitability. As the industry has matured, the requirement for adequate documentation to maintain compliance with local regulations across many of the emerging markets has grown. Maintaining regulatory dossiers and managing labels is necessary to uphold licenses, along with pharmacovigilance (PV) activities. Noncompliance with any stipulations can result in serious penalties, often with significant financial implications.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
David Balderson is Global Vice President Safety Operations at Sciformix Coporation and has over 18 years of experience in safety and regulatory operations. Throughout his career, he has been a key driver of process improvement initiatives, from the development of processes to support the EU Clinical Trial Directive through to the development of an electronic interface between the study and safety databases. David holds a BSc in physiology and pharmacology as well as a PhD in neuroscience, both from the University of Manchester, UK.
spacer
David Balderson
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

FlyPharma

FlyPharma Conferences and Pharma.Aero are joining together to support a collaborative platform for forward-thinking pharma and cargo professionals at this year’s FlyPharma Conference Europe, with a view to discussing key pharma supply chain challenges affecting all stakeholders.
More info >>

White Papers

Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan

Sepha Limited

Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
More info >>

 
Industry Events

T3: Trials, Tech and Transformation

30-31 May 2018, Raleigh Convention Center, Raleigh, NC

T3 is back for 2018 to provide you with the latest updates and top tips from across the clinical trials landscape. Connecting leading experts, influencers and innovators from pharma, biotech, CROs, patient advocacy groups, academia and beyond, T3 is themeeting place for all stakeholders to voice their questions, connect with peers, and get direct feedback from an expert speaker line-up.And this year, we're in Raleigh.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement