Annual Report of the Pharmacovigilance Inspectors Working Group for 2018
On 2 July 2020 the EMA announced the availability of the 2018 PV annual report.
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Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.
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Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
On 10 July 2020 the FDA announced the availability of the final guidance for industry and IRBs.
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Technical Notice to Sponsors Regarding Continuous Compliance with the EU Legislation for Clinical Trials Following the Withdrawal of the United Kingdom from the EU
On 9 July 2020 a joint technical notice to sponsors by the European Commission, EMA and HMA was published.
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China NMPA Guidance on the Management of Clinical Trials of Medical Products During COVID-19 Pandemic
On 14 July 2020 the Chine NMPA issued the draft guidance in Chinese for sponsors and investigators.
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