Connie

Entries by Connie
EudraLex Volume 4 Annexes - Annex 21

EudraLex Volume 4: EU Annex 21 GMP guidelines

EudraLex, Volume 4 – Good Manufacturing Guidelines
European Union: EU GMP Guide Updates – EU Annex 21 (News)

Manufacturers/Importers and Sponsors who import medicinal products into the EU/EEA must now comply with EU Annex 21 GMP requirements.

Background to EU Annex 21 …

Naloxone-access-programs-pilot-overdose

Naloxone Access Pilot Programs (FAQs)

Naloxone Access Pilot Programs (FAQs)
This article will review FAQs in relation to Naloxone Access Programs being rolled out in various jurisdictions, including the ‘Take Home Naloxone’ pilot program in Australia – and why these programs need your support.

Disclaimer: This …

overdose-stigma-research-2

Reducing Overdose Stigma, Saving Lives

“Reducing stigma, saving lives” is the final blog in the 10 blog series on overdose awareness and overdose prevention topics.

Did you miss the latest overdose research and overdose statistics report, released on the 31st of August 2021 (International …

Australian Overdose Statistics: An Interview with John Ryan

The latest Australian overdose statistics (2021)
This is blog 9 of 10 blogs in the overdose awareness and overdose prevention series.

The 31st of August is International Overdose Awareness Day.

We had the privilege of interviewing the Penington Institute’s CEO, John Ryan, …

GxP What-is-GxP-acronym-definition

What is GxP compliance?

Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.

What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?

GMP and GxP are pharmaceutical-industry quality standards and …

drug-safety-monitoring-overdose-2.j

Drug Safety Monitoring

Drug safety monitoring and overdose prevention
This is blog 7 of 10 blogs in the overdose awareness and overdose prevention series.

Drug safety monitoring is an important part of GMP/GxP compliance.
Drug safety monitoring includes pharmacovigilance as well as supply chain protection. …

egal-cases-opioid-crisis-settlements.

Opioid Crisis (Legal Cases)

Snapshot of the Opioid Crisis (Legal Cases)
This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series.

International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the …

pharmaceutical-product-diversion-risks-API-security

Diversion of Pharmaceutical Products: Prevention Measures

Diversion of prescription drugs
This is Blog 5 of 10 blogs in the overdose awareness and prevention series.

Diversion of pharmaceutical products is an ongoing concern in terms of overdose deaths, as diversions can lead to potent medical substances (such …

overdose-risks-synthetic-opioids-crisis

Opioids and overdose risks

Synthetic opioids and overdose harms
This is blog 4 of 10 blogs in the overdose awareness and overdose prevention series.

What are synthetic opioids? And what are the risks of synthetic opioid overdoses and other harms?

Synthetic opioids are prescribed for …