spacer
home > pmps > summer 2019 > why so persitently unruly?
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Why so Persitently Unruly?

Given how vital the practice is to international regulatory compliance and to keeping products safely on the market, it may be expected that global life sciences firms would have the production and management of patient-facing materials efficiently coordinated so that accuracy and speed to market were taken for granted. Nothing could be further from reality.

Undoubtedly, the global labelling management burden in life sciences has soared in recent years. Companies’ R&D ambitions are growing, businesses are expanding into more markets, and regulators are steadily strengthening safety requirements to protect patients from harm. Each time the benefit/risk profile or safety factors change, or as regional or local regulatory agencies update their standards, international biopharmaceutical firms must react swiftly with accurate, compliant labelling for all affected markets. If they fail to do so, they risk delays to shipping or even to keeping their product registrations on the market, with implications for sales, revenues, and reputation.

Given that all of these market conditions are set to intensify rather than diminish, finding a solution sooner is now a priority. Balancing market opportunity, risk, and cost is becoming increasingly tough to do, so it is unsurprising that organisations are keen to bring the situation under control. As the frequency of changes increases − due to ever-growing product complexity, heightened pharmacovigilance, and new regulatory specifications – the demand soars exponentially.

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
Agnes Cwienczek is a Senior Life Sciences Consultant at AMPLEXOR with a remit that includes the provision of business process and data management expertise in the areas of regulatory information management, document management, and submission management. Prior to joining AMPLEXOR, she worked at Merck in its Global Regulatory and Quality Assurance department. Agnes received her Master’s degree in Information Management from the University of Koblenz-Landau, Germany.
spacer
Anges Cwienczek
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Turkish Cargo maintains its steady growth.

According to the data obtained by WACD, the international air cargo information provider, in May; Turkish Cargo, the global air cargo brand providing service to 124 countries around the world, increased its tonnage rate by 7.1 percent, and grew substantially across the industry which shrank by 5.1 percent in the global air cargo market.
More info >>

White Papers

Clinical Trials in Emerging Markets: Goldmines or Landmines?

Pharm-Olam, LLC

Over the past decade, biopharmaceutical companies have increasingly turned to emerging markets as a way to reduce clinical trial costs and timelines. Areas such as Eastern Europe, India, and Latin America—with their ready population of treatment naïve patients—can be an answer to the intense competition for patients seen in developed markets. Many of the countries within these regions may now be considered as “emerged” countries but yet, conducting trials in these regions does require some special attention and expertise. Before deciding to conduct studies in these areas, companies should have a full appreciation for the ethical, medical, regulatory, legal, and operational hurdles that must be surmounted for success. Here we highlight a number of those issues and offer our recommendations for how sponsor companies can deal with them effectively.
More info >>

 
Industry Events

Pharmapack Europe 2020

5-6 February 2020, Paris Expo, Porte de Versailles - Hall 7.2 | Paris, France


More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement