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Are you preparing for Brexit? | Peter Gough | Pulse | LinkedIn
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Agnès Saint-Raymond, head of international affairs at the European Medicines Agency, said at a recent DIA forum that betting on a transition ...
CT Regulation implementation delay | Peter Gough | Pulse | LinkedIn
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The new Clinical Trials Regulation was published in the Official Journal of the EU on 28 May and the implementation plan ...
Draft Annex 1 published | Peter Gough | Pulse | LinkedIn
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The long awaited draft of the revised GMP Annex 1 on sterile products has been published on the PIC/S website but, oddly, it is not yet on the ...
EMA External 'Whistle-blower' Policy | Peter Gough | Pulse | LinkedIn
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The EMA Management Board has adopted a new policy on how EMA handles allegations of improprieties received from external parties.
EMA updates Brexit guidelines | Peter Gough | Pulse | LinkedIn
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The EMA has updated two of its Brexit guidelines. One is their “Questions and Answers related to the United Kingdom's withdrawal from the ...
EU-USA MRA starts | Peter Gough | Pulse | LinkedIn
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The U.S. FDA has determined that they will recognize eight European drug regulatory authorities as capable of conducting inspections of ...
MHRA Data Integrity Guidance | Peter Gough | Pulse | LinkedIn
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The UK MHRA has published guidance on data integrity that sets out their expectations for data integrity in GMP.
Name change for US FDA? | Peter Gough | Pulse | LinkedIn
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The Trump administration is proposing to change the FDA's name to the Federal Drug Administration and move the agency's food programs to ...
New EU GMP Legislation published | Peter Gough | Pulse | LinkedIn
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The European Commission has published new GMP legislation in the Official Journal of the EU. Directive covers GMP for marketed ...
New draft EU GMP legislation | Peter Gough | Pulse | LinkedIn
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On the 13 January the European Commission(EC) published a draft GMP Regulation for IMPs and a draft GMP Directive for marketed ...
Revised EU GMP Annexes published | Peter Gough | Pulse | LinkedIn
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Annex 2 has been revised as it is no longer applicable to Advanced Therapy Medicinal Products (ATMPs) following the publication of Part IV of ...
Revised EU IMP GMP | Peter Gough | Pulse | LinkedIn
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Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second ...
Why doesn't the Pharma/Bio industry use SPC? | Peter Gough | Pulse ...
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Almost all other manufacturing industries routinely conduct process trending using well-established Statistical Process Control (SPC) ...
EMA Nitrosamine Impurities Guidance - LinkedInwww.linkedin.com › pulse › ema-n...
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Peter GoughFollow. Vice President at NSF International, Health Sciences.
On-line Legal Update course | by Peter Gough | LinkedInwww.linkedin.com › pulse › on-line-legal-update-co...
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· Even during this difficult time, it is essential for Qualified Persons and other quality professionals to keep current with the latest ...
UK Brexit guidance | Peter Gough | Pulse | LinkedIn
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of a no deal Brexit. The guidance documents are on 'Batch ...
A BIG YEAR | by Peter Gough | LinkedInwww.linkedin.com › pulse › big-year-peter-g...
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· Peter GoughFollow. 23 years with the UK's most experienced provider of interaction recording, contact centre applications, PCI solutions and ...
New UK Combined Clinical Trial Application Process from 2022www.linkedin.com › pulse › new-uk-combined-clini...
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· More from Peter Gough articles. Revised FDA Guidance on CM&C Post-Approval Changes: Certain Biological Products ...
Revised FDA Guidance on CM&C Post-Approval Changes - LinkedInwww.linkedin.com › pulse › revised-fda-guidance-c...
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· Miscellaneous changes not specified in Appendix. Published By. Peter Gough. Vice President at NSF International, Health Sciences.
A on Manufacturing, Supply Chain, and Inspections During COVID-19www.linkedin.com › pulse › updated-fda-qa-manuf...
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· Thanks Peter Gough a useful document is the FDA Resiliency Roadmap for FDA Inspectional Oversight, issued this month.
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