eCopy Program for Medical Device Submissions
On 27 April 2020 the FDA issued the updated version of the guidance for industry and FDA staff providing clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.
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Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic
On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.
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International Compilation of Human Research Standards 2020 Edition
The Office for Human Research Protections U.S. Department of Health and Human Services compiled the 2020 edition of the international compilation of human research standards.
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Union Procedure on the Follow-up of Pharmacovigilance Inspections
On 30 April 2020 the EMA published this guideline effective 1 May 2020.
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New Branch of Widler & Schiemann AG in Germany
Widler & Schiemann AG announced Dr. Andreas Fischer will join as Managing Director for their new German affiliate opening on July 1st this year.
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