Risk Evaluation and Mitigation Strategies: Modifications and Revisions
On 29 June 2020 the FDA announced the availability of the final guidance for industry.
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Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials
On 29 June 2020 the EMA announced the availability of this guidance.
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Widler & Schiemann GmbH Germany Goes Live with Dr. Andreas Fischer, Managing Director
On 1 July 2020 Widler & Schiemann AG Announced New German Subsidiary.
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Pharmacovigilance Inspection Program Risk Assessment Survey
On 30 June 2020 the Australian TGA announced that the PVIP Risk Assessment Survey is open for medicine sponsors to complete.
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Questions and Answers: Qualification of Digital Technology-based Methodologies to Support Approval of Medicinal Products
On 1 June 2020 the EMA updated the Q&A document on the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.
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