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Latest report July 2022

Safety Observer 191

The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies.

Released 08-Jul-2022

Pages 34

Number of users	Clear

Highlights

Report 191 — Highlights

EMA & TTS

The EMA recently hosted a workshop to discuss the pathophysiology of thrombosis with thrombocytopenia syndrome (TTS), which has been associated with adenovirus-based COVID-19 vaccines.

EU “Big Data” project

The EMA has published a list of metadata describing real-world data sources and studies in a move intended to help researchers identify and use this information.

New ENCePP Guide

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has issued the tenth revision of its guide on methodological standards in Pharmacoepidemiology.

Australia & DAEN

The Australian Therapeutic Goods Administration (TGA) has announced the launch of a Beta version of the Database of Adverse Event Notifications (DAEN).

Past Reports

Safety Observer 190

The ANSM has published a revised version of the French Good Pharmacovigilance Practices.

Number of users

Clear

Highlights

Report 190 — Highlights

EU CTR: New Q&As

New guidance has been published in relation to the New EU Clinical Trials Regulation (EU CTR). The Q&A Document on the EU CTR has been revised and new Q&As published for Complex Clinical Trials and on the interface with the Regulation on in vitro diagnostic medical devices.

ANSM: French GVPs

The French Agency has published a revised version of the French Good Pharmacovigilance Practices (GVPs), which comes in replacement of the version issued in February 2018.

South Africa: New PV guidance

The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Systems”, which covers the requirements for the QPPV and PSMF, amongst others.

FDA: Medical Gases

The FDA has published a proposed rule that covers the postmarketing safety reporting requirements for certain medical gases.

Artificial Intelligence & PV

CIOMS has started a new Working Group XIV to cover Artificial Intelligence in Pharmacovigilance. The May issue of the “Drug Safety” journal also includes a series of articles on Artificial Intelligence and Machine Learning.

Highlights

Report 190 — Highlights

EU CTR: New Q&As

ANSM: French GVPs

The French Agency has published a revised version of the French Good Pharmacovigilance Practices (GVPs), which comes in replacement of the version issued in February 2018.

South Africa: New PV guidance

The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Systems”, which covers the requirements for the QPPV and PSMF, amongst others.

FDA: Medical Gases

The FDA has published a proposed rule that covers the postmarketing safety reporting requirements for certain medical gases.

Artificial Intelligence & PV

Safety Observer 189

The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports.

Number of users

Clear

Highlights

Report 189 — Highlights

FDA & E2B submissions

The US FDA has published the final guidance entitled “Providing Submissions in Electronic Format – Postmarketing Safety Reports”. The FDA also published updated guidance to help companies prepare their systems for the transition to the E2B(R3) format.

Canada: e-labelling

Health Canada has adopted interim implementation measures whereby companies can choose to use electronic platforms to complement physical labels for prescription medicines.

South Africa: PV Inspections

The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Inspections for Human Medicinal Products”.

Janssen COVID-19 Vaccine

The US FDA has announced its decision to limit the authorized use of the Janssen COVID-19 Vaccine to adults for whom no other COVID-19 vaccine can be used.

DILI e-learning

Following the publication of the consensus report on Drug-Induced Liver Injury (DILI) in September 2020, CIOMS and the UMC have produced the corresponding e-learning course.

Highlights

Report 189 — Highlights

FDA & E2B submissions

Canada: e-labelling

Health Canada has adopted interim implementation measures whereby companies can choose to use electronic platforms to complement physical labels for prescription medicines.

South Africa: PV Inspections

The South African Health Products Regulatory Authority (SAHPRA) has published a new guideline on “Pharmacovigilance Inspections for Human Medicinal Products”.

Janssen COVID-19 Vaccine

The US FDA has announced its decision to limit the authorized use of the Janssen COVID-19 Vaccine to adults for whom no other COVID-19 vaccine can be used.

DILI e-learning

Following the publication of the consensus report on Drug-Induced Liver Injury (DILI) in September 2020, CIOMS and the UMC have produced the corresponding e-learning course.

Safety Observer 188

The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).

Number of users

Clear

Highlights

Report 188 — Highlights

FDA: Device or Drug?

The FDA has issued an “Immediately in Effect Guidance” after a Court ruled that the FDA can no longer regulate as drugs the ophthalmic dispensers packaged together with ophthalmic drugs.

EMA Draft Guidance on PPP

The EMA has published a new draft GVP Module XVI Addendum III, which covers Pregnancy Prevention Programmes (PPP) and other Pregnancy-specific Risk Minimisation Measures.

France: Safety Reporting & EU CTR

The ANSM has published Module V and VI of the Notice to Sponsors, which clarify the safety reporting requirements for clinical trials under the new EU Clinical Trials Regulation (EU CTR).

Pakistan GVP Guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has published the first edition of the guidelines on Good Pharmacovigilance Practices for Product Registration Holders.

Malaysia GVP Inspections

The Malaysian authorities have issued guidance to support a new programme of voluntary Good Pharmacovigilance Practices (GVP) Inspections.

Highlights

Report 188 — Highlights

FDA: Device or Drug?

The FDA has issued an “Immediately in Effect Guidance” after a Court ruled that the FDA can no longer regulate as drugs the ophthalmic dispensers packaged together with ophthalmic drugs.

EMA Draft Guidance on PPP

The EMA has published a new draft GVP Module XVI Addendum III, which covers Pregnancy Prevention Programmes (PPP) and other Pregnancy-specific Risk Minimisation Measures.

France: Safety Reporting & EU CTR

The ANSM has published Module V and VI of the Notice to Sponsors, which clarify the safety reporting requirements for clinical trials under the new EU Clinical Trials Regulation (EU CTR).

Pakistan GVP Guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has published the first edition of the guidelines on Good Pharmacovigilance Practices for Product Registration Holders.

Malaysia GVP Inspections

The Malaysian authorities have issued guidance to support a new programme of voluntary Good Pharmacovigilance Practices (GVP) Inspections.

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Latest news

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June 6, 2022

ANSM issues revised French GVPs

By Thierry Hamard

July 7, 2022

COVID-19 Guidance & Updates

By Thierry Hamard

February 7, 2022

MHRA & GPvP Inspections

By Thierry Hamard

March 7, 2021

RSI in Clinical Trials: MHRA Findings and Tips

By Thierry Hamard

November 18, 2020

Risk Management & COVID-19 vaccines

By Thierry Hamard

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Safety Observer 191

Past Reports

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Latest news

ANSM issues revised French GVPs

COVID-19 Guidance & Updates

MHRA & GPvP Inspections

RSI in Clinical Trials: MHRA Findings and Tips

Risk Management & COVID-19 vaccines

Supporting the global Pharmacovigilance community since 2005

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