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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.

New court filing alleges Sanofi destroyed emails relating to Zantac recall

New court filing alleges Sanofi destroyed emails relating to Zantac recall

Among the deleted emails are those from Michael Bailey, Sanofi’s head of regulatory affairs for the US consumer healthcare division, according to Bloomberg. ... The regulatory agency said that the impurity found in some ranitidine products increases

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  • Piloting a route to the biosimilars opportunities in Europe Piloting a route to the biosimilars opportunities in Europe

    Investigating the EU regulatory hurdles that life sciences companies face as they seek to improve patient access to biosimilar therapy. ... Gabriela Marton is Regulatory Affairs Director and Quality Director at Arriello.

  • How can virtual pharma companies de-risk new product launches? How can virtual pharma companies de-risk new product launches?

    affairs. They also need access to broader business knowledge spanning financials, tax, legal, intellectual property tactics and commercial strategy. ... 5. Meeting market-specific compliance requirements. Finally, no product can reach the market without

  • Rethinking trials: the pros and cons of protocol amendments Rethinking trials: the pros and cons of protocol amendments

    Flexibility. Protocol amendments provide drug developers with the flexibility needed to conduct scientifically robust research, said Jenny Fam, Associate Director, Global Regulatory Affairs, IQVIA.

  • The handover: Pfizer reshapes itself for a new era The handover: Pfizer reshapes itself for a new era

    Executive vice president and chief development officer Rod MacKenzie will expand his responsibilities to include the company’s regulatory affairs function.

  • 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

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Latest appointments

  • New hires at EMA, Gilead and BeiGene New hires at EMA, Gilead and BeiGene

    In this role she leads WHO’s global work on health technologies regulation, including prequalification and regulatory systems. ... She has 30 years’ experience in international regulatory affairs, 18 years of which were in leadership roles.

  • New hires at Bristol-Myers Squibb, Acceleron and FerGene New hires at Bristol-Myers Squibb, Acceleron and FerGene

    He later advanced to the position of CMO and head of regulatory affairs. ... Prior to Celgene, he served as vice president, global medical affairs and safety at Pharmion.

  • New hires at Nanoform, Leo Pharma and Calliditas New hires at Nanoform, Leo Pharma and Calliditas

    The combination of his strong experience in regulatory affairs, not only with the FDA but on a broad international basis with a proven track record and experience from orphan drug development ... Bringstrup brings over 17 years’ experience in the

  • Amryt Pharma appoints new regulatory affairs head Amryt Pharma appoints new regulatory affairs head

    O’Carroll has over 25 years’ experience in the pharmaceutical industry and regulatory affairs business. ... Prior to joining Amryt, she served as senior director of regulatory affairs for rare disease group Retrophin.

  • Sanifit appoints Alexander Gold chief medical officer Sanifit appoints Alexander Gold chief medical officer

    In addition, his work in regulatory and medical affairs will be invaluable as we continue to take our novel clinical programmes through to approval.”.

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Latest from PMHub

  • Freyr Solutions

    Freyr is a Global Regulatory Solutions and Services company, focusing on the entire Regulatory value-chain ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions to post approval maintenance, Labeling, Artwork Change Management

  • Driving Healthcare Decisions with Natural Language Processing

    Dr. Sabita Sankar, VP of Business Development at HUMA.AI, discusses “human-centric AI” and how to automate healthcare through human language, with special focus on the applications for Medical Affairs, ... Clinical, Regulatory, and Commercial Pharma

  • Global Link Language Services, Inc.

    regulatory affairs, medical devices, medical documentation, marketing communication, and informed consent forms.

  • DDI LLC

    DDi is a prominent Technology partner to the Life Sciences industry. DDi has built its solution competency with a unique blend of functional and domain expertise to serve the technology needs of global clients.

  • Carrot Pharma Recruitment

    Marketing, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Clinical Research.

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