Dr Tatsuya Kondo

PMDA’s “Rational Medicine” Initiative

By Tatsuya Kondo, MD, PhD Found in: Article, Patient Engagement, Devices & Diagnostics, Safety & Pharmacovigilance, Medical Devices & Diagnostics, Regulatory Affairs

Throughout my clinical practice experience, I have always believed that medical care must be administered on the basis of the...

Making News in Europe

By John Lisman Found in: Article, Regulatory Affairs, Clinical Research, Devices & Diagnostics, Public Policy / Law

Three themes are hijacking the news in Europe at this point in time. The first two are refugees and terrorism. These issues have…

Mobile Medical Applications for Dosage Recommendation

By Muthu Kumar Murugiah, BPharm, MBA, DBA; Rajendran Muthuveloo, BEng, MBA, PhD; Yee Chang Soh, BPharm, MClinPharm; Vanni Caruso, MPharm, PhD; Rahul Patel, BPharm, MPharmSci, PhD; Long Chiau Ming, BPharm, MClinPharm, PhD Found in: Article, Devices & Diagnostics, Medical Devices & Diagnostics

There is a need for a collation and comparison of the content of the mobile medical applications (apps) to allow health care...

New EU Medical Devices & In Vitro Diagnostic Regulations

By Erik Vollebregt Found in: Article, Regulatory Affairs, Devices & Diagnostics

The EU Commission has just finalized the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The…

Validation of Computer Systems With Smart Devices

By Yumi Wakabayashi, MBA, BS; Hitoshi Matsui, BS; Kohji Ikai, BS; Masahiro Hayashi, BS; Hiroyuki Wakabayashi, MA; Keiichi Yamamoto, PhD Found in: Article, Clinical Data Management / eClinical, Devices & Diagnostics

The use of smart and/or wearable devices for collection of electronic data in clinical trials has recently become a strong...

What Device are YOU Wearing Today?

By Jackie S. Hoover Found in: Article, Investigator Site, Devices & Diagnostics, Clinical Research

New technology and the incredible amounts of data that is and will be generated from various digital health applications and innovations…

FDA QS Implementation for CoDx Lab-Developed Tests

By Joshua D. Levin, Kennita N. Riddick and Eunice Y. Lee Found in: Article, Regulatory Affairs, GLP, Quality Assurance, Quality Control, Devices & Diagnostics

FDA’s guidance document for in vitro companion diagnostic devices (IVD CoDx) states that, ideally, an IVD CoDx is approved at…

Global Forum Special Section: Social Media @DIA

By Brandon King Found in: Article, Anti-doping, Academic Health Centers, Alternative / Herbal Med, Biotechnology, Clinical Data Management, CMC, Safety & Pharmacovigilance, Clinical Research, Clinical Supplies, Devices & Diagnostics, Medical Communications, Managed Health, Medical Writing

Social media is essentially like talking to someone, just through your respective computers, iPhones, smart devices or other electronic or digital tool.

Clinical Trials Ready to Embrace the IoE?

By Richard Strobridge Found in: Article, Clinical Trial Disclosure, Clinical Research, Devices & Diagnostics, Medical Devices & Diagnostics

The Internet of Everything (IoE) is having an enormous impact. With Gartner listing the IoE as one of the top ten strategic...

Dr Tatsuya Kondo

PMDA’s “Rational Medicine” Initiative

By Tatsuya Kondo, MD, PhD Found in: Article, Patient Engagement, Devices & Diagnostics, Safety & Pharmacovigilance, Medical Devices & Diagnostics, Regulatory Affairs

Throughout my clinical practice experience, I have always believed that medical care must be administered on the basis of the...

Making News in Europe

By John Lisman Found in: Article, Regulatory Affairs, Clinical Research, Devices & Diagnostics, Public Policy / Law

Three themes are hijacking the news in Europe at this point in time. The first two are refugees and terrorism. These issues have…

Mobile Medical Applications for Dosage Recommendation

By Muthu Kumar Murugiah, BPharm, MBA, DBA; Rajendran Muthuveloo, BEng, MBA, PhD; Yee Chang Soh, BPharm, MClinPharm; Vanni Caruso, MPharm, PhD; Rahul Patel, BPharm, MPharmSci, PhD; Long Chiau Ming, BPharm, MClinPharm, PhD Found in: Article, Devices & Diagnostics, Medical Devices & Diagnostics

There is a need for a collation and comparison of the content of the mobile medical applications (apps) to allow health care...

New EU Medical Devices & In Vitro Diagnostic Regulations

By Erik Vollebregt Found in: Article, Regulatory Affairs, Devices & Diagnostics

The EU Commission has just finalized the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The…

Validation of Computer Systems With Smart Devices

By Yumi Wakabayashi, MBA, BS; Hitoshi Matsui, BS; Kohji Ikai, BS; Masahiro Hayashi, BS; Hiroyuki Wakabayashi, MA; Keiichi Yamamoto, PhD Found in: Article, Clinical Data Management / eClinical, Devices & Diagnostics

The use of smart and/or wearable devices for collection of electronic data in clinical trials has recently become a strong...

What Device are YOU Wearing Today?

By Jackie S. Hoover Found in: Article, Investigator Site, Devices & Diagnostics, Clinical Research

New technology and the incredible amounts of data that is and will be generated from various digital health applications and innovations…

FDA QS Implementation for CoDx Lab-Developed Tests

By Joshua D. Levin, Kennita N. Riddick and Eunice Y. Lee Found in: Article, Regulatory Affairs, GLP, Quality Assurance, Quality Control, Devices & Diagnostics

FDA’s guidance document for in vitro companion diagnostic devices (IVD CoDx) states that, ideally, an IVD CoDx is approved at…

Global Forum Special Section: Social Media @DIA

By Brandon King Found in: Article, Anti-doping, Academic Health Centers, Alternative / Herbal Med, Biotechnology, Clinical Data Management, CMC, Safety & Pharmacovigilance, Clinical Research, Clinical Supplies, Devices & Diagnostics, Medical Communications, Managed Health, Medical Writing

Social media is essentially like talking to someone, just through your respective computers, iPhones, smart devices or other electronic or digital tool.

Clinical Trials Ready to Embrace the IoE?

By Richard Strobridge Found in: Article, Clinical Trial Disclosure, Clinical Research, Devices & Diagnostics, Medical Devices & Diagnostics

The Internet of Everything (IoE) is having an enormous impact. With Gartner listing the IoE as one of the top ten strategic...