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Overall, the problem is we don't have a competent regulatory framework that prevents things from going horribly wrong.
We aimed to design a decision tree based on a series of studies included in actual dossiers approved by competent regulatory authorities, noting that the design, execution and interpretation of pharmacokinetics studies using this type of therapy is not straightforward and presents a challenge for both developers and regulators.
Patients depend on professional, competent regulatory oversight.
Thus, systematic oral health surveillance in the Czech Republic should be promoted by competent regulatory authorities.
Oral health surveillance in the Czech Republic should be promoted by competent regulatory authorities.
Furthermore, the Ethics Committee(s) and competent regulatory authorities themselves may decide to stop or suspend the trial.
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The paper also highlights other challenges facing Jordan in its pursuit of nuclear power such as opaque decision-making process and the need for an independent and competent nuclear regulatory body.
The reporting criteria for adverse events is shown in Figure 2. The trial manager is undertaking duties delegated by the trial sponsor and is responsible for reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) and other Serious Adverse Reactions (SARs) to the competent authorities (regulatory authorities and central research ethics committees).
As for cell dose, according to our first-in-man experience and data available in literature [ 4, 13, 37], we agreed about safety purposes with the competent Italian regulatory body (Istituto Superiore di Sanità, ISS) to set at 10 × 10 the highest CD133+ cells dose.
3. Member States may make provision for the competent national regulatory authorities jointly to decline to resolve a dispute where other mechanisms, including mediation, exist and would better contribute to resolving of the dispute in a timely manner in accordance with the provisions of Article 8.
1. Member States shall ensure that in order to implement Article 13a, competent national regulatory authorities have the power to issue binding instructions, including those regarding time limits for implementation, to undertakings providing public communications networks or publicly available electronic communications services ║.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com