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Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight | Hogan Lovells


The future of inspections under FDA’s COVID-19 PREPP initiative
(MRI).
On January 13, FDA published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched internally in April 2020 and announced publicly in August 2020. According to the summary report, the PREPP initiative is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.” Notably, these action areas include “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst” and “strengthen[ing] supply chain surveillance for regulated products,” suggesting that several of FDA’s COVID-related inspection pilot projects will continue into the future. ....

United States , Hogan Lovells , Chain Surveillance Task , Drug Administration , Mutual Reliance Initiative , Pandemic Recovery , Preparedness Plan , Action Area , Bioresearch Monitoring , Supply Chain Surveillance Task Force , Good Manufacturing Practice , ஒன்றுபட்டது மாநிலங்களில் , ஹோகன் லவ்ல்ஸ் , சங்கிலி கண்காணிப்பு பணி , பரஸ்பர நம்பகத்தன்மை முயற்சி , சர்வதேச பரவல் மீட்பு , ப்ரிப்யாரெட்நெஸ் திட்டம் , நடவடிக்கை பரப்பளவு , பிோரேசஎஅர்ச் கண்காணிப்பு , விநியோகி சங்கிலி கண்காணிப்பு பணி படை , நல்ல உற்பத்தி ப்ர்யாக்டீஸ் ,

Mutual Reliance Initiative


To enhance the effectiveness of development cooperation, we are one of the partners in the Mutual Reliance Initiative (MRI), which sees the Bank join forces with the French Agency for Development (AFD) and Germany’s KfW Development Bank.
The initiative allows the promoters of investment projects co-financed by the three development institutions in EU partner countries to benefit from a larger project finance capacity through a structured division of labour.
Blending expertise
The EIB, KfW and AFD are all significant players in European external action, but they work under different regulations, statutes and legal and governance structures.
Under this initiative, most of the tasks during the project cycle are given to one of the three institutions as a lead financier, from appraisal to preparing lending decisions and implementation. The lead financier is appointed because they will have particular expertise in a given economic sector, or a significant presence in ....

United States , Germany Kfw Development Bank , French Agency For Development , Mutual Reliance Initiative , French Agency , Kfw Development , Sub Saharan Africa , North Africa , Operational Guidelines , Latin America , Eastern Europe , 2011 063 , ஒன்றுபட்டது மாநிலங்களில் , பரஸ்பர நம்பகத்தன்மை முயற்சி , செயல்பாட்டு வழிகாட்டுதல்கள் , லத்தீன் அமெரிக்கா , கிழக்கு யூரோப் ,