EMA and FDA present guidelines for AI in drug development
EMA and FDA present guidelines for AI in drug development
4 months ago
heise.de
Apotex receives first FDA tentative approval for generic version of semaglutide injection in partnership with Orbicular
Apotex receives first FDA tentative approval for generic version of semaglutide injection in partnership with Orbicular
1 month ago
marketscreener.com
Biosimilar medicines: Overview | European Medicines Agency (EMA)
Biosimilar medicines: Overview | European Medicines Agency (EMA)
May 5, 2017
europa.eu
OS Therapies (NYSE American: OSTX) announced that the FDA has granted a second Type C meeting scheduled for December 11, 2025, and the UK MHRA has granted a pre-MAA meeting for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1. The announcement highlighted the company’s progress toward regulatory submissions following success
0:13
OS Therapies (NYSE American: OSTX) announced that the FDA has granted a second Type C meeting scheduled for December 11, 2025, and the UK MHRA has granted a pre-MAA meeting for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1. The announcement highlighted the company’s progress toward regulatory submissions following success
1K views7 months ago
FacebookB2i Digital
The 2026 EMA–FDA Guiding Principles of Good AI Practice
20:53
The 2026 EMA–FDA Guiding Principles of Good AI Practice
5 views3 weeks ago
YouTubeJayant Joshi
PMDA Washington D.C. Office initiatives
8:22
PMDA Washington D.C. Office initiatives
23 views1 month ago
YouTubePmda Channel
Case Study: Predictive Regulation Regulatory oversight is becoming more data-driven. This case study explores how predictive monitoring and analytics are shaping the future of regulatory expectations across global life sciences markets. #RegulatoryCompliance #LifeSciences #FDA #EMA #DataDriven #EMMAInternational
1:52
Case Study: Predictive Regulation Regulatory oversight is becoming more data-driven. This case study explores how predictive monitoring and analytics are shaping the future of regulatory expectations across global life sciences markets. #RegulatoryCompliance #LifeSciences #FDA #EMA #DataDriven #EMMAInternational
51 views2 months ago
TikTokemmaintconsulting
0:37
Now out 🎙️ Regulatory oversight is evolving. Agencies like the FDA and EMA are increasingly using data analytics and real-world evidence to identify risks earlier and guide oversight. In this episode preview, we explore how predictive regulation is shaping the future of compliance across the life sciences industry. 🎧 Predictive Regulation: How FDA, EMA & Global Agencies Are Using Data to Shape the Future 🔗 Link in bio #LifeSciences #RegulatoryAffairs #PharmaIndustry #Compliance #EMMAInternati
36 views2 months ago
TikTokemmaintconsulting
2026 EMA-FDA AI Practice Guidelines Explained | Dr. Jayant Joshi posted on the topic | LinkedIn
10.1K views3 weeks ago
linkedin.com
Pharma News: Rusan Pharma Orbicular s FDA Approval | Chemxpert Database posted on the topic | LinkedIn
3 weeks ago
linkedin.com
PV Updates: FDA & EMA Team Up, EU Regulations, AI Integration | OshVi Solutions posted on the topic | LinkedIn
2 months ago
linkedin.com
Global Generic Drug Affairs
Jan 25, 2021
fda.gov
2:31:50
Process Validation Regulatory & Practical View
26.9K viewsJul 18, 2020
YouTubeHitendrakumar Shah
7:57
Pharmacovigilance guideline E2B(R3) PART-1
19.8K viewsMar 3, 2018
YouTubePharmaHybrid
23:53
Nitrosamines: Where Are We Now?
3.7K viewsMar 11, 2021
YouTubeU.S. Food and Drug Administration
1:26
New sleep apnea device gets FDA approval
114.8K viewsMay 12, 2014
YouTubeCBS News
7:22
Drug discovery and development process
704.8K viewsJan 14, 2011
YouTubeNovartis
7:38
How Does the FDA Approve a Drug?
194.4K viewsJul 20, 2015
YouTubeHealthcare Triage
1:03:08
Understanding the IN VITRO DIAGNOSTIC REGULATION (IVDR) Everything You Need to Know
19K viewsOct 28, 2020
YouTubeLabroots
0:14
Regulatory Updates Form Across Europe
May 9, 2025
VimeoDDREG Pharma
57:10
Cleanroom Masterclass: How to Successfully Design and Build Your Cleanroom
14.9K viewsNov 20, 2020
YouTubeThomas Scientific
9:25
What are oligonucleotide therapeutics, and how do they work?
15.5K viewsApr 6, 2021
YouTubeCertara
11:04
Marketing Authorisation in EU| European Medicines Agency (EMA)| MRP, DCP, CP & National Procedure
30K viewsApr 20, 2020
YouTubePharma Learners
10:24:52
What is Clinical SAS ? | Clinical SAS Programming tutorials for Beginners🔥🔥🔥
223K viewsJan 3, 2020
YouTubeGreat Online Training
1:22:14
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
17.3K viewsNov 3, 2020
YouTubeU.S. Food and Drug Administration
25:35
Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification
4.3K viewsMar 11, 2021
YouTubeU.S. Food and Drug Administration
11:18
Training recording: how to submit an application for orphan medicinal product designation using IRIS
881 viewsMar 1, 2022
YouTubeEuropean Medicines Agency
1:00:02
Nitrosamine Impurities | USP
5.7K viewsNov 30, 2020
YouTubeUS Pharmacopeia
5:16
Case Narrative Writing Trailer
12K viewsSep 12, 2014
YouTubeKathy Barnett
1:27:38
FDA-EMA Parallel Scientific Advice (PSA) Program
5.9K viewsMar 18, 2022
YouTubeU.S. Food and Drug Administration
See more
Static thumbnail place holder