Adis

Adis launches services to support pharmacovigilance departments

Adis Pharmacovigilance will help pharmacovigilance teams to face the challenges of regulatory literature monitoring. Under the name of Adis Pharmacovigilance, Adis, a leading global provider of drug information, has launched an expanded range of services to support pharmacovigilance departments. This new suite of services includes monitoring special situation Individual Case Safety Reports (ICSRs), local literature and customised source coverage, ongoing …

Drug Safety Europe 2016

Ensuring Compliance for Cloud: A Risk Management Guide for Life Sciences Organizations

In an effort to manage cost pressures, optimize operational efficiencies, and build robust IT capabilities, the life sciences industry is also shifting to the cloud. However, being a highly regulated industry, players face significant compliance challenges while leveraging the cloud. In addition to managing security risks in a shared computing environment, organizations also need to ensure that regulatory commitments are …

Q2 2016 Cloud

Q2 Pharmacovigilance and Drug Safety Conferences – What did you miss?

Q2 Pharmacovigilance and Drug Safety Conferences – What did you miss? Great industry conferences are often the result of a combination of factors: good planning, strong speakers, with real depth in expertise and a passion for their topic, and attendees/delegates with great questions.  When all three line up in one event, all participants gain tremendous value from the presentations and …

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

At BioPharma India Convention 2014, Samuel Raj Solomon, PhD., RAC (US & EU) Sr. Manager & Head -Biosimilars Regulatory Sciences, Biocon Ltd. India presented on the topic : Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production. Download the presentation to learn: Central Dogma Of Biosimilars Manufacturing Regulatory Compliance For Biosimilars Manufacturing Systematic Risk And Science Based Approach – CQA Hallmarks Of Pivotal CMC …

Ebook: Your essential guide on trends, regulations and new technologies in Drug Safety

Drug safety must continue to evolve to meet heightened patient expectations and the fluctuating regulatory climate. It is becoming critical to exploit opportunities offered by emerging technologies, big data and personalised healthcare. To succeed in this new environment, we need to assess the regulatory updates; we need to examine how to implement regulations strategically and operationally in addition to discussing …

Embracing big data and emerging technologies in drug safety

Which new approaches are pharma companies taking to exploit opportunities offered by big data? We’ll be answering this question and many more as we discuss big data and related innovative technologies at World Drug Safety Congress Europe. Hear from a plethora of thought leaders who will be sharing real life examples of how to develop big data programmes and social media …

Addressing the key challenges for drug safety professionals

The regulatory environment is fast changing and the drug safety industry is facing significant hurdles in implementing standards globally. It is becoming increasingly challenging to meet all regulatory requirements effectively in the current globalised marketplace. Stay on top of pharmacovigilance requirements with updates directly from the regulators, agencies and industry who will show you how to implement regulatory standards globally. Learn …

Thomson reuters report

Thomson Reuters press-release: World Generic Medicines Congress Europe

The World Generic Medicines Congress Europe organized by Health Network Communications brought together industry stakeholders, decision makers, and experts for two days of presentations and discussions focused on market challenges and portfolio strategy. The industry has seen a collapse of traditional commodity generic models, while a new model is emerging from innovation and consolidation, supported by strategic geographic expansion. The …

HPAPI Safety

What is the key to safe highly potent active pharmaceutical ingredient (HPAPI) manufacturing?

Innovating highly potent active pharmaceutical ingredient (HPAPI) production philosophies can ensure safety for those involved in their manufacturing, but what are the best pathways to innovate whilst reducing risks?   The fast growing HPAPI sector fosters huge potential, and with an annual growth rate exceeding double figures, it has become something of a ‘promised land’ to many CMOs. The market …

video, patient, strategy, safety, patient safety, drug safety

Big opportunities for improving patient safety

What is Pharma’s biggest opportunity for improving patient safety over the next 5-10 years?  This question was posed to several attendees at last year’s World Drug Safety Congress Europe event.  Watch the video for their answers. Hear from: Christina Stoem Moeller, Astra Zeneca Logesvaran Yogendran, Janssen Pharmaceuticals Logesvaran Yogendran, Janssen Pharmaceuticals Marqus Hamwright, UCB Pharma Dr Simon Ingate, Pope Woodhead …