PharmaSoft İlaç Bilişim Danışmanlık Hizmetleri

Name: PharmaSoft İlaç Bilişim Danışmanlık Hizmetleri
Address: Fetih Mahallesi, Istanbul, 34704, TR
Telephone: +902163267712

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Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from PharmaSoft İlaç Bilişim Danışmanlık Hizmetleri, Consulting Agency, Fetih Mahallesi, Istanbul.

Sözleşmeli Farmakovijilans Hizmet Kuruluşu olarak, Sağlık Bakanlığı Tıbbi Cihaz ve İlaç Kurumu tarafından sertifikalandırılan şirketimiz sizlere farmakovijilans yükümlülükleriniz konusunda destek sağlar.

07/05/2026

We were pleased to join the pharmacovigilance course at Yeditepe Üniversitesi Faculty of Pharmacy.

As part of the course led by Prof. Dr. Hande Sipahi, our General Manager, M.Sc. Pharm. Rabia Ayse Cetin, shared her professional experience and industry insights with the students.

Following this, our colleagues Pharmacovigilance Team Leader Betül Domaç and Quality Assurance Team Leader Gizem Dülger Gün contributed to the session with presentations on pharmacovigilance and medical device vigilance, sharing practical perspectives from the field.

It was a meaningful opportunity for us to meet future pharmacists, contribute to safety awareness, and support the connection between academic learning and real-life industry practice.

We would like to sincerely thank Prof. Dr. Hande Sipahi for her kind invitation.

We also extend our sincere thanks to Prof. Dr. Hülya Akgün, Dean of the Faculty of Pharmacy, and Prof. Dr. Hande Sipahi for their warm hospitality and gracious hosting.

03/04/2026

PharmaSoft ACADEMY is now live!

A new destination for professional learning in the pharmaceutical industry.

Explore the New Destination for Learning!

Explore our training programs on our website.

17/02/2026

Artificial Intelligence is no longer theoretical in pharmacovigilance.

It is becoming operational.

We attended the inaugural International Society of Pharmacovigilance European Artificial Intelligence Seminar in Basel, hosted at the Novartis Campus.

Under the theme “AI Powered Pharmacovigilance: Humans in the Loop,” the discussions focused on how artificial intelligence can be responsibly integrated into pharmacovigilance systems.

The message was clear.

AI can accelerate case processing, literature monitoring and signal detection.

Accountability, validation and regulatory responsibility remain human.

As AI adoption expands in drug safety, sustainable innovation will depend on this balance.

05/02/2026

We are pleased to support the official MedDRA MSSO training courses taking place in Istanbul!

The programme will include:

Coding with MedDRA – 05 March 2026
MedDRA: Safety Data Analysis and SMQs – 06 March 2026

This training will be delivered by an official MedDRA trainer: Jane Knight (MedDRA MSSO) Trainer profile: https://www.meddra.org/msso-trainers?trainer=Jane%20Knight

The training is organised and supported by PharmaSoft, with venue support from the University of Health Sciences.

We look forward to meeting you at the training in Istanbul!

26/01/2026

🚨 EMA Signal Management Update: Key Changes for 2026

The European Medicines Agency (EMA) has released an updated version of its Signal Management Questions & Answers document (Rev 5), bringing it in line with upcoming regulatory changes. Here’s a breakdown of the key revisions:

🔑 Key Changes in the Update:

1️⃣ Deletion of Question 5 The question regarding EudraVigilance monitoring requirements has been removed, as the responsibility is now fully assigned to MAHs starting August 2025.

2️⃣ Updated MAH Responsibilities MAHs are now explicitly required to monitor EudraVigilance routinely and use it as a core safety data source.

3️⃣ Technical Update for Centrally Authorised Products A minor technical clarification was introduced for data submission related to centrally authorised products.

4️⃣ PRAC Recommendations Become Binding Starting January 2026, PRAC recommendations for signal management are now legally binding. MAHs must act on these recommendations, which now include defined timelines, variation types, and substance-wide applicability.

📌 For pharmacovigilance and regulatory professionals:

◽ Update your internal signal management SOPs. ◽ Ensure EudraVigilance monitoring processes are compliant by August 2025.

◽ Prepare for binding PRAC variations starting January 2026.

🔗 Visit us at www.pharmasoft.com.tr for detailed guidance and tools to help you stay ahead in pharmacovigilance and regulatory compliance.

20/01/2026

EMA & FDA set common principles for AI in medicine development.

Artificial Intelligence is no longer limited to innovation labs.

It is now used across the entire medicinal product lifecycle, from non clinical development to post marketing and manufacturing.

📄 With their joint publication, the European Medicines Agency and the U.S. Food and Drug Administration send a clear message.

AI can support drug development and pharmacovigilance, but only if it is governed properly.

Key expectations are clear:
◼️ AI must be explainable, traceable, and verifiable
◼️ Risk based validation and appropriate oversight are essential
◼️ Lifecycle management is mandatory rather than optional
◼️ Decisions based solely on “because the model says so” are no longer acceptable

🧩 For pharmacovigilance and regulatory affairs teams, this represents a clear shift.

AI is becoming part of the compliance landscape rather than just a technical tool.

Innovation remains critical.

However, innovation does not replace compliance.

AI is no longer optional, governance is mandatory.

🔗 To see how these principles translate into practice, learn more about PharmaSoft’s AI driven PV and RA solutions at: www.pharmasoft.com.tr

Address

Fetih Mahallesi
Istanbul
34704

Telephone

+902163267712

Website

http://www.pharmasoft.com.tr/

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