European Pharmaceutical Review

JULY 25, 2022

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

Safety 116

Safety Consulting Healthcare Healthcare 116

European Pharmaceutical Review

SEPTEMBER 5, 2023

He is currently a CMC consultant with an interest in impurities and safety‑based limits. Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. Org Process Res Dev. 2023; 10.1021.acs.oprd.3c00008.

Pharmaceutical 97

Pharmaceutical Medicine Consulting Marketing 97

pharmaphorum

AUGUST 4, 2022

AR has developed enormously over the last few years, meaning that highly visual step-by-step guidance and training procedures can be delivered to employees to ensure they follow safety protocols without being exposed to actual real-life risks in the manufacturing facility. About the Author. She joined NSF in 2017. appeared first on.

Recruitment 98

Recruitment Training Pharma Pharmaceutical manufacturing 98

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Following publication of the proposal, the European Commission launched an eight-week public consultation. However, the eight-week period was quickly shortened to eight days.

Medical 117

Medical Government Marketing Medicine 117

PM360

SEPTEMBER 28, 2022

This was back in 2004/2005 when we were just hearing about biosimilars for the first time and they were the great unknowns. I hear many times whether it’s from consultants, vendors, customers, or other colleagues, how some of them profess to be experts in the biosimilar space. I don’t believe that for a minute.

Competition 98

Competition Marketing Manufacturing Biopharma 98

European Pharmaceutical Review

FEBRUARY 28, 2023

He is currently a CMC consultant with an interest in impurities and safety‑based limits. Questions and Answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. Available from: [link] 10.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Medicine 98

European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103