Belgium censured over REACH penalties failure

Published: 17-May-2011
Regulatory

ECJ insists countries punish companies that fail to comply


Belgium has been censured by the European Court of Justice (ECJ) for failing to impose penalties on companies breaching the rules of EU chemical control system REACH. The court said Belgium had “failed to fulfil its obligations” under EU law. If Belgium does not now establish a system of punishments, it could face court fines.
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Overcoming CMC challenges in cell and gene therapy: part II

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Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs

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  1. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  2. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  3. Momentum in the US cannabidiol market gains retailers' attention Walmart and other big-name stores in talks with food and drinks makers in preparation for the day CBD-enriched products are allowed on the shelves
  4. Ametek Mocon achieves accreditation for analytical testing laboratory Ametek Mocon, provider of instruments and services for testing, measuring and analysing a variety of gases, has achieved ISO/IEC 17025 accreditation for its Minneapolis analytical testing laboratory
  5. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena

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Regulatory

Overcoming CMC challenges in cell and gene therapy: part II

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
Regulatory

Overcoming CMC challenges in cell and gene therapy: part I

Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
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AskBio receives FDA Fast Track Designation for congestive heart failure gene therapy programme

The fast-tracking allows the development and expedition of review processes for AB-1002, a gene therapy to promote production of a constituently active form of I-1c
Manufacturing

Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success

Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
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Isospec Analytics launches biomolecular analysis technology to identify unknown molecules

The novel technology optimises the identification process of unknown molecules compared to mass analysis
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4SC AG receives Paediatric Investigation Plan waiver for resminostat from the UK MHRA

The waiver allows the company to avoid investigating the CTCL drug in a paediatric population, as it's considered unnecessary or inappropriate for use by this patient group
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The key role of IVDs in healthcare: challenges to commercialisation and access

In simple terms, in vitro diagnostic (IVD) tests are done on samples such as blood or tissue that have been taken from the human body. IVDs can detect diseases, conditions and infections, provide patients with a better understanding of their ailment and how it might be managed and changed with treatment
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