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EMA guidance aims to prevent medicine shortages

European Pharmaceutical Review

A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.

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India Pharma Inc in M&A mode once again

Express Pharma

These workshops are set to continue over the next few months. However, annual audits would add to the documentation and administrative cost of doing business, especially painful for the MSME sector. This is clearly linked to instances of Made in India cough syrups found to contain high levels of the toxic diethylene glycol (DEG).

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Dossiers: A new way of alleviating the disorganization of patient experience data

Putting Patients First Blog

The dossier model and disease-specific dossiers would be living documents updated over time, with patient organizations being the lead owners of these data. A PED dossier template would describe a consistent format (e.g., expected headers and content). representativeness of research to date, known unknowns). Key findings are underway.

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SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference

pharmaphorum

Workshops: 29 April 2022. SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference is taking place in Boston on April 27-28, 2022, with interactive workshops on April 26, 2022. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.

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Pre-Filled Syringes East Coast 2022

pharmaphorum

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Workshop Leader: Theresa Jeary, Technical Specialist & Scheme Manager, BSi. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion.

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5th Annual Pharmaceutical Microbiology West Coast Conference

pharmaphorum

Interactive Post Conference Workshop June 22, 2022. Workshop Leaders: Ziva Abraham, President, Microrite and Morgan Polen, SME Cleanroom Contamination Control, Microrite. Join industry experts to discuss the latest topics and pressing challenges in this field. Cleanroom Qualification-Common Missteps. View the full agenda: [link].

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EMA launches quality control group to aid medicine innovation

European Pharmaceutical Review

Prepare guidance documents related to innovative quality and manufacturing technologies . Contribute to pharmaceutical quality-related workshops or training for EU assessors and GMP inspectors.