Monday Weekly Summary (08.04 – 14.04.2024)

? Monday Weekly Summary: Stay informed with the latest regulatory updates!

In the fast-paced world of regulations, staying updated is key to success. We’ve gathered a comprehensive list of regulatory updates from last week (08.04 – 14.04.2024) to keep you informed about the latest changes in the pharmaceutical industry. Check out the links below for essential insights and ensure compliance with the ever-evolving landscape.

? What’s new about AIDIFY?

Join us for the first training in a series dedicated to the practical use of ChatGPT and Generative AI in the pharmaceutical industry. This is a unique opportunity to understand what ChatGPT is and how its capabilities can be leveraged in daily work. During interactive workshops, participants will learn how to effectively formulate prompts and engage in dialogue with AI to optimize the management of adverse action cases. This is a unique chance to gain practical skills that will significantly increase your productivity and professional efficiency.

? Limited free spaces available! Stay tuned for details!

?  Scientific Articles  

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies

Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination

?  Recommendations/Regulations/Guidelines/Instructions/FAQs

FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products

Pharmaceutical quality of inhalation and nasal products – Scientific guideline

Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Guidance on real-world evidence provided by EMA: support for regulatory decision-making

Institutional Review Boards Frequently Asked Questions

Process for Handling Referrals to FDA Under 21 CFR 50.54 – Additional Safeguards for Children in Clinical Investigations

Nonclinical Safety Evaluation of Pediatric Drug Products

Statement from the Polish HA President dated April 5, 2024, regarding products manufactured by public health institutions under Regulation (EU) 2017/746.

FDA released – New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry

? Reports

N/A

?Trainings/Presentations/Invitations

Exciting Seminar Announcement: Unveiling the Role of Artificial Intelligence in Pharmacovigilance

SPOR Data Update

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day 1

Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access – Day 2

Cancer Medicines Forum workshop

Regulatory Education for Industry (REdI) Annual Conference 2024: Biologics Track

Regulatory Education for Industry (REdI) Annual Conference 2024: Devices Track

Regulatory Education for Industry (REdI) Annual Conference 2024: Drugs Track

Clinical Trials Information System (CTIS): Walk-in clinic – March 2024

Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS

?  News/Press Releases

WHO unveils a digital health promoter harnessing generative AI for public health

WHO Member States agree to resume negotiations aimed at finalizing the world’s first pandemic agreement

?️ Meeting agendas/minutes/summary

Committee for Advanced Therapies (CAT) meeting with interested parties new, Online, European Medicines Agency, Amsterdam, the Netherlands, 16 May 2023

Minutes of the 122nd meeting of the Management Board, 13-14 December 2023

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024

Agenda of the PRAC meeting 8-11 April 2024

Minutes of the PRAC meeting 5-8 February 2024

Final Minutes – HMA-EMA joint Big Data Steering Group teleconference – 22 March 2024

?Product opinion/decisions/updates

Emend (aprepitant) supply shortage

? Other

EMA systems disruption expected from 11 to 17 April

Learn about Traineeship Opportunities at EMA

Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)

Contacts at the European Medicines Agency

Services and databases

#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters