Lini Subin @lintreesa

Managing Director Silmed Scientific ; #RegulatoryAffairsConsultant, #EMA, #DCP, #CMC, #module3, #eCTD, #variation, #dossierwriting, #regulatoryintelligence, silmedscientific.com Bengaluru, India Joined February 2011

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Lini Subin @lintreesa

2 years ago

Ensayos clínicos con medicamentos de uso humano aemps.gob.es/medicamentos-d…

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Lini Subin @lintreesa

3 years ago

#BuildForTheWorld Door3 Really Great Experience @investkarnataka

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EU One Health @EU_Health

4 years ago

The @WHO_Europe estimates that nearly half a million lives were saved in Europe, thanks to vaccination A reduction of 51% in estimated total fatalities #VaccinesWork #HealthUnion

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IFPMA @IFPMA

4 years ago

Pleased to see discussions at #EABF touch on the importance of the #AfricanMedicinesAgency! @AfricanAmata members explain why financial & technical support is needed to enable the agency to begin operations. #AfricaEU

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António Guterres @antonioguterres

4 years ago

We must not miss a once-in-a-generation opportunity to strengthen our response to & recovery from #COVID19 through bold, creative solutions. We need a new social contract, based on solidarity and investments in education, green jobs, social protection, & access to health care.

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Rahul Gandhi @RahulGandhi

5 years ago

This is what happens when the PM runs a country in the sole interest of 3-4 crony capitalists.

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EU Medicines Agency @EMA_News

6 years ago

At its January meeting, EMA’s Committee for Advanced Therapies (CAT) re-elected Dr Martina Schüssler-Lenz as its chair, for a second three-year mandate. Congratulations! 👉ema.europa.eu/en/news/martin…

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EU Medicines Agency @EMA_News

6 years ago

UK withdrawal from the EU on 31 January 2020: During the transition period, EU pharmaceutical law will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of the year. 👉ema.europa.eu/en/news/uk-wit…

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EU Medicines Agency @EMA_News

6 years ago

.@ICH_news is organising a public meeting (31 Oct 2019, at the @US_FDA headquarters) to review the draft E8 Guideline ‘General Considerations for #ClinicalTrials’. Those interested can attend in person or follow the event via webcast: ema.europa.eu/en/news/global…

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EU Medicines Agency @EMA_News

6 years ago

EMA and @US_FDA are aligned in > 90% of marketing authorisation decisions for new #medicines 💊, as shown by joint analysis of 107 new medicine authorisations from 2014 to 2016: 👉ema.europa.eu/en/news/emafda…

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Lini Subin @lintreesa

6 years ago

Brazils ANVISA has published the Common Technical Document (CTD) Guide for the Registration of Medicine. It will reduce the time and resources required for drug registration. [email protected]; #regulatoryaffairs, #ANVISAconsultant, #BRAZIL, #CTD, #Biologics, #registration

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Lini Subin @lintreesa

6 years ago

EMA has recommended change in names of liposomal medicines to avoid errors and MAHs to submit a variation to change the names of these medicines as soon as possible and before the end of Sep2019. Contact: [email protected] #raconsult, #variation, #liposomal #patientsafety

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EU Medicines Agency @EMA_News

6 years ago

EMA’s paediatric committee (#PDCO) wants to hear the views of young patients with X-linked #retinitis_pigmentosa, a rare #eyedisease, on a potential new gene therapy. Fill in the survey until 16 August: ec.europa.eu/eusurvey/runne… #retinitis #XLRP #EMAPublicConsultation

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Priyanka Gandhi Vadra @priyankagandhi

6 years ago

उन्नाव बलात्कार मामला व पीड़िता के पूरे परिवार को प्रताड़ित करना सत्ता के सरंक्षण के बिना सम्भव नहीं। अब परतें खुल रही हैं व भाजपा नेताओं के नाम और पुलिस की लीपापोती सामने आ रही है। कांग्रेस न्याय के लिए प्रतिबद्ध है। ये लड़ाई हम मज़बूती से लड़ेंगे। #UnnaoKiBeti

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UP Congress @INCUttarPradesh

6 years ago

"एक आँसू भी हुकूमत के लिए ख़तरा है, तुम ने देखा नहीं आँखों का समुंदर होना.." सोनभद्र हत्याकांड के पीड़ितों का दर्द बांटते हुए श्रीमती @priyankagandhi जी। #PriyankaFightsForPeople

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Lini Subin @lintreesa

6 years ago

Can't resist posting #SareeTwitter in evergreen Kerala

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Lini Subin @lintreesa

6 years ago

#GMP, #Inspection #EUGMP, #FDA

EU Medicines Agency @EMA_News

6 years ago

#GMP, #Inspection #EUGMP, #FDA

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EU Medicines Agency @EMA_News

6 years ago

#DYK that the EU 🇪🇺 and the United States 🇺🇸 have now fully implemented the mutual recognition agreement for inspections of manufacturing sites for certain human medicines in their respective territories? 👉 ema.europa.eu/en/news/eu-us-…