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risk management

This page shows the latest risk management news and features for those working in and with pharma, biotech and healthcare.

Biopharma industry encouraged by EMA’s COVID-19 transparency measures

Biopharma industry encouraged by EMA’s COVID-19 transparency measures

Additional measures, following marketing authorisation, are set to include publication of the complete version of the risk management plan and clinical trial data used to support regulatory approval of all

Latest news

  • Alkermes’ new antipsychotic clears FDA advisory committee hurdle Alkermes’ new antipsychotic clears FDA advisory committee hurdle

    The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met to discuss ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with ... stimulation. This increased weight

  • Digital divergence Digital divergence

    I have no empirical data on these cases, but it is reasonable to hypothesise that big pharma and ‘little digital’ probably look at deals through very different risk-management lenses. ... The issue will be how to jointly understand, manage and

  • J&J gets EU approval for depression nasal spray Spravato J&J gets EU approval for depression nasal spray Spravato

    Approved with a risk management plan to guard dosing. Johnson &Johnson can market its treatment-resistant depression drug Spravato on both sides of the Atlantic, now that the EMA has followed ... Spravato is also approved with a risk management plan

  • Pharma Brand Planners' Blog (Part 7) Pharma Brand Planners' Blog (Part 7)

    A small word of caution: in your risk management approach, it’s worth tuning in to your organisational culture – what’s your organisation’s appetite for risk? ... How open is your senior management to a realistic and aggressive approach to risk

  • The new basics The new basics

    The same concept will spread to tax management, competitive strategy and investment strategy. ... Crucially, they are also much better at demonstrating that better risk management too.

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Latest Intelligence

  • Launch engagement Launch engagement

    Now they have to think of something new. “What we have seen is that companies can be comfortable with risk, providing it is based on insight, knowledge and innovation. ... The need for due diligence across risk- management and a tight control on

  • An EU emergency health fund to limit the impact of future crises An EU emergency health fund to limit the impact of future crises

    The Facility follows the growth of market-based risk financing facilities across global and regional initiatives, led by the World Bank. ... Specifically, the EHFF is a health risk management tool that provides liquidity when it is most needed, without

  • New strategic blueprint: the new first questions New strategic blueprint: the new first questions

    on the strategy table is risk – and risk management. ... And internally, the shifts to new technologies and new ways of working represent both a changing management challenge and a huge mid-term opportunity.

  • A market-adapted agile approach to launch excellence A market-adapted agile approach to launch excellence

    Detailed competitor insights enable launch team alignment around opportunities for differentiation and risk identification; in particular, assessing anticipated access hurdles in the context of competitive insight is essential. ... ambitions. Relentless

  • Stakeholder dialogue in Europe’s adaptive pathways pilot Stakeholder dialogue in Europe’s adaptive pathways pilot

    The involvement of multiple stakeholders in discussing the product development programme and risk management so that the company can plan how to meet their demands. ... Payers participated in only one case in which they provided high-level comments on a

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Latest appointments

  • Astellas appoints ethics and compliance and US legal leaders Astellas appoints ethics and compliance and US legal leaders

    litigation and risk management. ... Most recently, she served as associate general counsel, focusing on regulatory, life cycle management, drug quality and manufacturing.

  • Dr June Raine continues as chair of EMA's pharmacovigilance committee Dr June Raine continues as chair of EMA's pharmacovigilance committee

    Dr Raine is director of vigilance and risk management of medicines at the Medicines and Healthcare products Regulatory Agency (MHRA) and has served as PRAC chair since it was set up ... Evaluating the public health benefits of its

  • Adaptimmune appoints former GSK executives Adaptimmune appoints former GSK executives

    Meanwhile Rawcliffe will lead Adaptimmune's financial management and operations functions including compliance and risk management. ... Each brings a wealth of invaluable experience to complement the expertise of our existing senior management team.”.

  • EMA's Dr Stella Blackburn joins Quintiles EMA's Dr Stella Blackburn joins Quintiles

    Cynthia Verst, president, real world and late phase research at Quintiles, said: “Stella's experience developing innovative risk management solutions is a tremendous addition to our team. ... Blackburn will be responsible for leading the group's risk

  • WHO appoints two regional directors WHO appoints two regional directors

    We will focus on promoting universal health coverage, robust health systems and strengthening emergency risk management in South East Asia,” said Khetrapal Singh.

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Latest from PMHub

  • Risk Management, Ethics, and Compliance Considerations in the New Normal

    Head of Ethics, Risks and Compliance - Oncology, Novartis Canada, dissects the importance of effective patient engagement and strong compliance &monitoring programs. We also dive into the legal and ethical considerations around novel digital

  • Harness the power of data to map new patient pathways

    In terms of patient management, industry could, for example, identify and risk stratify patients who are highly likely to develop further complications while waiting for treatment and devise ways to safely ... So, a company specialising in pain management

  • What is changing in cardiovascular disease care?

    Improving the detection and management of high-risk conditions, such as high blood pressure, high cholesterol and Atrial Fibrillation (AF) that can cause CVD, as well as many cases of dementia, ... it to diagnose and treat those at genetic risk of

  • A new vision for tackling key illnesses

    Detecting patients at risk of CVD and preventing the disease from occurring will be key to helping the NHS achieve its ambition. ... There will be a big focus on lifestyle improvements for at-risk patients, particularly weight management, as well as

  • World Diabetes Day: Interaction and impact of diabetes on mental health

    Moreover, depression and diabetes distress can increase patient risk for mortality, poor disease management, poor quality of life, work absenteeism and other diabetes-related complications [15, 17]. ... and Sreedevi, A., 2013. National recommendations:

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