News from GMP Market and about Valicare
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Valicare
16h of January 2020: Bosch Packaging Technology becomes Syntegon Technology
30th of July 2019: ECA certified API Production Manager & certified APIC Auditor
27-29th of June 2019: Strategy meeting of Slovak Valicare s.r.o. in Turna
24th of June 2019: Valicare Slovakia opens new location in Turná
12th of June 2019: J.P. Morgan Corporate Challenge in Frankfurt
5-6th of June 2019: Infomeeting der Valicare GmbH in Würzburg
19th of March 2019: ZellTherQC-Workshop at EBM in Lübeck
1th of October 2018: Valicare GmbH welcomes five new employee at Frankfurt am Main
14th of November 2017: Valicare GmbH celebrates its 15th anniversary
13th September 2017: Valicare advises start-ups and biotech companies on GMP compliance
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GMP market
30th of July 2019: Medical cannabis is a medicinal product
28th of February 2018: End of transition period for EN ISO 13485:2016
28th of February 2018: The new draft of Annex 1 of the EU GMP guideline
28th of February 2018: New Aide memoire of ZLG for process validation
18th of December 2017: Iran/IFDA, Turkey/TMMDA and Mexico/COFEPRIS are new members of PIC/S
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ATMP
17th of January 2020: BioNTech SE acquires Neon Therapeutics
9th of January 2020: New legal regulations governing the application of ATMPs
24th of September 2019: How to handle Out-of-Specification (OOS) batches of ATMPs?
17th of September 2019: Valicare expresses its support for the RESTORE Consortium
20th of March 2019: Patient free of HIV after stem-cell therapy
13th of March 2019: The crux of penicillin application in cell culture for ATMP manufacturing
31th of January 2019: Draft guideline on the requirements for ATIMPs in clinical trials, EMA
22th of November 2017: European Commission, EC, adopts GMP for ATMP Guideline
30th of October 2017: New action plan to foster development of advanced therapies
1st of September 2017: Response to ATMP GMP Guideline
2th of July 2017: Cell-based gene therapy for the ALL treatment receives FDA approval
19th of June 2017: “Annual Report 2016” of EMA indicates a positive trend for ATMP
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pack insights
30th of August 2019: Good Manufacturing Practice (GMP)
23th of April 2019: Ensure your Compliance of Good Distribution Practice (GDP)
6th of December 2018: Validation-from concept to implementation
22th of February 2018: Filling of sterile injectables – validation of high-tech equipment
18th of September 2017: ATMPs – patient-specific drugs on their way to market
23th of June 2017: GMP audits & inspections in the pharmaceutical industry