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Regulatory affairs

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

Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy

Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy

Dr Maria Pascual, vice president of regulatory affairs and corporate quality at TiGenix, said: “This approval of Alofisel reflects our deep understanding and recognised leadership in the development of allogeneic stem

Latest news

  • PharmaLex expands its footprint to Italy PharmaLex expands its footprint to Italy

    Development consulting and affairs group PharmaLex has expanded its operations to Italy, opening a new office in Milan. ... Acting as a base for PharmaLex Italy, the new location will be headed by regulatory affairs specialist Fulvia Feltrin, who will

  • CHMP backs Europe’s first allogeneic stem cell therapy CHMP backs Europe’s first allogeneic stem cell therapy

    TiGenix ’s vice president regulatory affairs, María Pascual, said this first approval recommendation or an allogeneic stem cell therapy in Europe “reflects the maturity of our technology and its potential to

  • TiGenix’s Crohn's fistulas treatment wins orphan drug status TiGenix’s Crohn's fistulas treatment wins orphan drug status

    therapy. Dr Maria Pascual, vice president regulatory affairs and corporate quality, TiGenix, said: “The granting of orphan drug status by the FDA is a significant step forward in the Cx601 development ... Meanwhile, TiGenix and partner Takeda has said

  • Ready for takeoff? Ready for takeoff?

    These regulatory pathways include Accelerated Assessment, Conditional and Exceptional Marketing Authorisation, Compassionate Use Programmes and the Adaptive Pathway. ... is global head of regulatory affairs at Novella Clinical. 10th November 2016.

  • ICON boosts leadership teams ICON boosts leadership teams

    regulatory and medical affairs, medical writing, medical imaging and interactive technologies.

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Latest Intelligence

  • Brexit Means Brexit Brexit Means Brexit

    strong overtones of working together) where products only need to undergo one series of approvals, in one country, to show that they meet the required regulatory standards. ... There’s a mature market for outsourced regulatory affairs in Europe so

  • Legal and regulatory affairs

    Healthcare terms - Legal and regulatory affairs.

  • Hacking Innovation Hacking Innovation

    I think those of us in corporations, like RB, are in a very privileged position to make a difference in the world, ”said RB’s vice president of global regulatory affairs

  • European CTR implementation advances ethical assessment of clinical trials European CTR implementation advances ethical assessment of clinical trials

    Timelines are becoming stricter with regard to the fact that compatibility with Regulatory Authority (RA) assessment must be ensured. ... is director of regulatory affairs at contract research organisation KCR. 7th August 2017.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    To support early drug development and speed up the evaluation and approval process, the EMA has encouraged the industry to seek early interaction via scientific advice with the regulatory and health ... are regulatory affairs consultants and Johan

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Latest appointments

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Latest from PMHub

  • Augmented Reality in patient communication – don’t miss out!

    References:. Pierre Corin, Genentech. “ Electronic informed consent – improving patient engagement”, Brian Bollwage, JD, VP Global Regulatory Affairs, Chiltern CRO.

  • Regulatory affairs

    We’ ve built our reputation for quality, reliable and responsive EU regulatory affairs consulting with major healthcare companies worldwide. ... TRAC Services are a regulatory affairs consultancy who help pharmaceutical companies meet the regulatory

  • Eames.Jones.Judge.Hawkings

    We recruit from executive level upwards in medical, clinical research, regulatory affairs, sales, marketing, R&D, quality control, production, human resources, general management, and market research.

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