Search
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...
Sharan Murugan
May 7, 20232 min read
332 views
0 comments
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...
Sharan Murugan
Apr 29, 20231 min read
38 views
0 comments
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...
Sharan Murugan
Apr 23, 20231 min read
182 views
0 comments
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...
Sharan Murugan
Mar 11, 20231 min read
205 views
0 comments
EMA Procedural Advice: Recommendations on Unforeseen Variations
Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...
Sharan Murugan
Feb 27, 20231 min read
180 views
0 comments
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators
On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory...
Sharan Murugan
Feb 25, 20231 min read
27 views
0 comments
EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...
Sharan Murugan
Feb 14, 20231 min read
321 views
0 comments
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...
Sharan Murugan
Jan 16, 20232 min read
70 views
0 comments
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...
Sharan Murugan
Nov 12, 20221 min read
35 views
0 comments
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...
Sharan Murugan
Nov 4, 20221 min read
298 views
0 comments
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...
Sharan Murugan
Nov 4, 20221 min read
433 views
0 comments
EMA Guidance: Scientific Advice and Protocol Assistance
European Medicines Agency (EMA) recently updated (14-October-2022) its guidance on "Scientific advice and protocol assistance" and also...
Sharan Murugan
Oct 17, 20221 min read
285 views
0 comments
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
Recently EMA released an updated guidance document for the purpose of simplifying the completion of the application form process for...
Sharan Murugan
Oct 13, 20221 min read
214 views
0 comments
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
Earlier on 27th Spetmber, 2022 EMA revised and released their updated Regulatory and procedural guideline on "Checking process of...
Sharan Murugan
Sep 30, 20222 min read
454 views
0 comments
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
Sharan Murugan
Sep 4, 20221 min read
10 views
0 comments
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...
Sharan Murugan
Sep 1, 20221 min read
60 views
0 comments
EMA: Updated EudraVigilance Registration Manual
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...
Sharan Murugan
Aug 25, 20221 min read
41 views
0 comments
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...
Sharan Murugan
Aug 12, 20221 min read
12 views
0 comments
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...
Sharan Murugan
Jul 31, 20221 min read
329 views
0 comments
EMA Guidance: Prevention of Medicine Shortages in the EU
Recently EMA released new guidance for "patients and healthcare professionals’ organisations" with key principles and examples of good...
Sharan Murugan
Jul 26, 20221 min read
9 views
0 comments