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

29/12/2025

2025 was a year of growth, structure, and consistency for PharmaSoft 🚀

From global pharmacovigilance operations to regulatory affairs, we supported complex workflows, expanded our footprint 🌍, and stayed true to one principle: compliance done right.

Moving into 2026 with the same mindset and stronger experience.

Discover our solutions: www.pharmasoft.com.tr

Follow us for more!

01/12/2025

📘 Did You Know?

PharmaSoft celebrates its 10th anniversary, marking a full decade of building Türkiye’s most trusted pharmacovigilance and regulatory technologies. 🎉

From launching the country’s first locally developed PV database PharmaBASE, to automating literature monitoring with PharmaSEARCH, and advancing AI powered signal detection with DetectIO, we have spent 10 years powering safer and smarter drug safety. 💊 🛡️

A decade of innovation.

A decade of digital pharmacovigilance and Regulatory Affairs.

And we are just getting started. 🚀

28/11/2025

Ten years of measurable impact across global PV systems.

A decade of building technology that reshaped how PV and regulatory teams operate.

Over the past 10 years, we supported 6000+ products, delivered 5000+ end-to-end PV & RA projects, worked with 250+ pharmaceutical partners, and expanded into 40+ countries with consistently 100% satisfaction.

These numbers matter not because they are big but because each represents safer medicines, faster decisions and stronger compliance for the industry we serve.

As we enter our next decade, our focus remains unchanged: developing reliable, intelligent and future-ready PV technology for global teams.

The journey continues.

26/11/2025

Ten years. One vision.

Smarter, faster and safer pharmacovigilance. 🚀

Our journey began in 2015 with the digitalization of literature monitoring through PharmaSEARCH.

Not long after, PharmaBASE became Türkiye’s first locally built pharmacovigilance database and the backbone of modern PV operations.

The following years brought MoH authorization, global industry engagement, expanding partnerships and the arrival of our AI-powered signal detection platform DetectIO.

Today, the PharmaSoft Suite unifies all our technologies into one ecosystem that powers literature monitoring, case management and signal intelligence, enabling stronger and more connected PV systems than ever before.

And this is still only the beginning.
Here’s to the next decade of innovation, growth and future-ready pharmacovigilance. 🎉

Address

Fetih Mahallesi
Istanbul
34704

Telephone

+902163267712

Website

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

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