CLINIMINDS REGULATORY AFFAIRS UPDATE
- FDA's New Guidelines on Pharmaceutical ContaminantsThe FDA has released updated guidelines addressing the presence of N-Nitrosamines, a group of impurities found in some pharmaceutical products. These guidelines are part of the FDA's ongoing efforts to ensure drug safety and protect public health by setting acceptable intake levels for these potentially carcinogenic compounds Read more
- EMA's Revised Monograph for Propylene GlycolThe European Pharmacopoeia Commission has adopted a revised monograph for Propylene Glycol in response to contamination concerns involving ethylene glycol and diethylene glycol. This revision aims to enhance public health safety by including stringent testing requirements Read more
- New Regulations on Micro Pollutants in EuropeThe European Parliament has mandated the removal of micro pollutants from wastewater before its release or reuse. This directive requires significant investment in wastewater treatment facilities, impacting urban areas with over 150,000 residents by 2030, and all critical zones by 2045 Read more
- Launch of EMA's Consultation on Pharmaceutical Process ModelsThe EMA has opened a consultation on pharmaceutical process models, seeking stakeholder input on regulatory guidance for continuous manufacturing and digital novel technologies. This initiative is part of the Quality Innovation Group's efforts to update regulatory expectations Read more
- FDA's Single Inspection Program PilotThe FDA, in collaboration with international regulatory agencies, has launched the Single Inspection Program (SIP) to streamline GMP inspections of third-country manufacturers. This pilot program aims to reduce the need for multiple inspections and improve regulatory efficiency Read more
- Japan Approves Shionogi's COVID-19 TreatmentJapan's Ministry of Health, Labour, and Welfare has approved Shionogi's Xocova, a COVID-19 treatment. This approval marks a significant advancement in the country's efforts to combat the pandemic with innovative therapeutic options Read more
- India's New Guidelines on Medical DevicesIndia has introduced new guidelines for medical device regulation to align with global standards. These guidelines focus on ensuring product safety and efficacy while promoting innovation and improving patient outcomes Read more
- EMA Updates on Vaccine Working Party PlansThe EMA has published updated work plans for its Vaccine Working Party, outlining strategic goals and projects for 2022-2024. These plans emphasize the importance of vaccine safety, efficacy, and quality Read more
- FDA Public Workshop on Accreditation Scheme for Conformity AssessmentThe FDA will hold a virtual public workshop on the expansion of the Accreditation Scheme for Conformity Assessment (ASCA). The workshop aims to enhance the understanding and implementation of ASCA among device manufacturers and sponsors Read more
- US FDA's Warning on Device Testing by Third PartiesThe FDA has issued a reminder to device manufacturers to independently verify performance testing results conducted by third parties. This reminder underscores the importance of ensuring accuracy and reliability in device testing Read more
Advanced Post Graduate Diploma Drug Regulatory Affairs and IPR & Patents - Cliniminds
Cliniminds Drug Regulatory Affairs and IPR & Patents Program is India’s well-established program since 2004. This program today is the industry standard, and students are trained on what industry requires as per global standards.
Next batch of the weekend program is commencing from Sunday, 25th August 2024.
For this batch, free Add on Advanced Post Graduate Diploma in Pharmacovigilance has been included. This would open for you opportunities in the Pharmacovigilance domain, which is integral part of the regulatory affairs.
For personal counselling, please call us at 9310485979 or 9560102589 or mail us at info@cliniminds.com or
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