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You are here: Pharmya > Articles by: Philippe Calandra
List of medicines under additional monitoring
2021 March Mar 02

List of medicines under additional monitoring

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.

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The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods
2021 February Feb 26

The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods

Australia-TGA’s risk management approach to the regulation of therapeutic goods_Feb2021

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ANSM – Ongoing clinical trials
2021 February Feb 22

ANSM – Ongoing clinical trials

Covid 19 – Ongoing clinical trials

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CMDh – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
2021 February Feb 19

CMDh – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

EU-Practical guidance for procedures related to Brexit_Jan2021

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
2021 February Feb 15

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-february-2021

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EMA consults on revised Risk Minimization GVP module XVI
2021 February Feb 12

EMA consults on revised Risk Minimization GVP module XVI

EU-GVP – Module Risk Minimisation Measures_draft update 01Feb2021

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MHRA – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
2021 February Feb 08

MHRA – Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
2021 February Feb 05

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021

Thirteen new medicines recommended for approval

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List of medicines under additional monitoring
2021 February Feb 01

List of medicines under additional monitoring

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.

Read more
Australia – Pharmacovigilance obligations of medicine sponsors
2021 January Jan 29

Australia – Pharmacovigilance obligations of medicine sponsors

https://www.tga.gov.au/pharmacovigilance-obligations-medicine-sponsors

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Pharmya – Pharmacovigilance

PHARMYA is a French based company, dedicated to providing Pharmacovigilance services. Its mission is to support the pharmaceutical industry, biotechnology companies, research centers and their service providers in their efforts to comply with international Pharmacovigilance regulations.

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  • 315 Av. Saint Sauveur du Pin
  • 34980 Saint Clément de Rivière (Montpellier), France
  • Phone: +33 411 93 21 10
  • Email: info@pharmya.com
  • Website: www.pharmya.com

News

  • List of medicines under additional monitoring
  • The Therapeutic Goods Administration’s risk management approach to the regulation of therapeutic goods
  • ANSM – Ongoing clinical trials
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