Regulatory

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Anticipate future challenges early, Pharmatech urges

”Don’t be left short-changed post approval – plan in change orders early for accelerated pathways,” Stephanie Gaulding said in her keynote address...

Pharmapack Europe 2022 award winners announced

A record number of commendations were awarded by the judges, based on the overall high standard of entries

DSCSA 2023 compliance update and timelines

The US DSCSA was enacted on Nov 2013 and since then we have seen a phased approach from the US FDA to implement the requirements

ICH Q12 toolbox and change management

With present day circumstances including the pandemic affecting almost all sectors of society, the pharmaceutical industry is gravitating towards a...

NHRA Bahrain serialisation guideline for pharma companies

The National Health Regulatory Authority in Bahrain plays a key role in ensuring expected health standards are met

Top 5 Pharma Supply Chain Trends in 2022

The pharmaceutical industry faces several issues and challenges regarding agility and automation in their process with no room for mistakes

How can my business improve environmental management?

Did you know that, according to the World Meteorological Organisation (WMO), temperatures were around 1.09 °C higher than the 1850-1900 period from...

Deciding on a chemistry, manufacturing and control strategy for biologic development

Khanh Ngo Courtney from Avomeen discusses what biopharmaceutical companies should keep in mind as they embark on their CMC journey

How to stay up-to-date with pharmaceutical developments?

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Serialisation master data

There are high risks associated with managing master data if the organisation does not have the right tool or personnel managing the system

Supporting global decentralised and virtual clinical trials during challenging times and beyond

Decentralised clinical trials (DCTs) utilising direct-to-patient (DTP) services, including the provision of drug products, ancillary supplies and h...

The new regulatory world for medical devices

Establishing an effective compliance strategy now ahead of the 2022 IVDR legislation is critical — because there’s more to come

Vetter participates in third University of St. Gallen benchmarking

Previously, the company’s microbiology and chemical analysis departments received positive ratings in their benchmarkings

How can we ensure compliance with the revised Annex 1?

Christian Dunne, Head of Sterility Assurance at ChargePoint Technology, explores what the industry can expect to see in the new Annex 1 legislation...

AstraZeneca antibody combination approved for COVID prevention

Evusheld is a combination of tixagevimab and cilgavimab, which has been shown to effectively prevent against COVID variants including omicron

Why outsourcing makes sense for orphan and rare diseases

There are as many as 8000 rare diseases, affecting 400 million people worldwide, for which there are no effective drugs available.<sup>1</sup> With...