How to Prepare for a Safety Inspection

Postmarket Surveillance Contributes to Device Innovation

By Claus Zippel, Sabine Bohnet-Joschko Found in: Article, Medical Devices & Diagnostics, Safety & Pharmacovigilance

Recent years have seen great interest in finding new ways to develop innovative, safe, and effective medical devices. While...

DIA Webinar To Discuss How Technology and Collaboration Can Reinvent the Clinical Trial

Found in: Article, Clinical Research, Clinical Supplies, Safety & Pharmacovigilance, CMC

Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.

Development of a Clinical Study Report

Ten-Year CDER Experience: Ensuring Patient Safety Part 2

By Jonathan P. Jarow, MD; Steven Lemery, MD, MHS; Kevin Bugin, MS, RAC; Naomi Lowy, MD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of...

Brexit’s Implications for Pharmacovigilance within the UK & Europe

By Dr. David Jefferys Found in: Article, Public Policy / Law, Safety & Pharmacovigilance

The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...

Managing Pharmacovigilance Outsourcing Partners

By Annette Williams Found in: Article, Outsourcing, Regulatory Affairs, Safety & Pharmacovigilance

Biopharmaceutical companies are facing increasing pressure to develop more robust pharmacovigilance programs, with teams...

Postmarket Surveillance Contributes to Device Innovation

By Claus Zippel, Sabine Bohnet-Joschko Found in: Article, Medical Devices & Diagnostics, Safety & Pharmacovigilance

Recent years have seen great interest in finding new ways to develop innovative, safe, and effective medical devices. While...

Ten-Year CDER Experience: Ensuring Patient Safety Part 2

By Jonathan P. Jarow, MD; Steven Lemery, MD, MHS; Kevin Bugin, MS, RAC; Naomi Lowy, MD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

The purpose of this study was to describe the role of the US Food and Drug Administration (FDA) in ensuring the safety of...

Brexit’s Implications for Pharmacovigilance within the UK & Europe

By Dr. David Jefferys Found in: Article, Public Policy / Law, Safety & Pharmacovigilance

The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...

Managing Pharmacovigilance Outsourcing Partners

By Annette Williams Found in: Article, Outsourcing, Regulatory Affairs, Safety & Pharmacovigilance

Biopharmaceutical companies are facing increasing pressure to develop more robust pharmacovigilance programs, with teams...

Customer Engagement Programs in Pharmacovigilance

By William Gregory, PhD Found in: Article, PE / Quality of life / Health, Safety & Pharmacovigilance

More than 15 years ago, the CIOMS V Working Group observed that, “The recent widespread use of special post-marketing programs...

Reference Safety Information in Clinical Trials: Increased EU Focus and Updated Guidance

By Esteban Herrero-Martinez, PhD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

Sponsors performing clinical trials in the EU must determine whether serious adverse reactions (SARs) to investigational...

Pharmacovigilance Programme of India: SWOT Analysis

By Dr J. Vijay Venkatraman Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for its...

Brexit Implications: Pharmacovigilance in UK & Europe

By Dr. David Jefferys Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

The UK’s vote in June 2016 to leave the European Union could have profound implications for the pharmaceutical sector in the...

Pharmacovigilance Programme of India: SWOT Analysis

By Dr J. Vijay Venkatraman Found in: Article, Safety & Pharmacovigilance, Regulatory Affairs

In recent years, pharmacovigilance (PV) has become a high priority, growing public health concern worldwide. India, for...

Vaccine Policy Reform in Japan: Progress & Challenges

By Yoshikata Furuya Found in: Article, Safety & Pharmacovigilance, Public Policy / Law, Regulatory Affairs

It is said that there is a “vaccine gap” between Japan and other developed countries. Indeed, the number of available...

Industry Lessons for Pharmacovigilance Outsourcing

By Bert P. van Leeuwen, MD; Christine Prendergast, MSc; Brian Edwards, MD, MRCP; Barbara Dawson, BSc(Hons) Found in: Article, Safety & Pharmacovigilance, Outsourcing

Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for...

Community Focus: Clinical Safety & Pharmacovigilance

By Catherine Baldridge, Dr. Elizabeth Garrard Found in: Article, Safety & Pharmacovigilance, Professional Development

The DIA Clinical Safety & Pharmacovigilance (CSP) Community aims to help foster best practices, new ideas, and serve as an...

iPLEDGE: Patient Access in Restrictive RMPs

By Kirk W. Kerr, PhD; Marta E. Wosinska, PhD Found in: Article, Safety & Pharmacovigilance, PE / Quality of life / Health, Regulatory Affairs

The isotretinoin risk management program iPLEDGE places requirements on patients and providers to ensure that the benefits...

Social Media Monitoring and Adverse Drug Reactions

By Marina Lengsavath, MSc; Anne Dal Pra, PharmD; Anne-Marie de Ferran, PharmD; Sabine Brosch, MPharm, RN; Dr. Linda Härmark, PharmD, PhD; Victoria Newbould, MSc; Susana Goncalves, PharmD Found in: Article, Regulatory Affairs, Safety & Pharmacovigilance

In the context of the European Union’s Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug...

The "Glory" of Drug Safety

By Dr. Tatsuo Kurokawa, DIA President Found in: Article, Safety & Pharmacovigilance

When I was a young boy in pharmacy school, I thought that a pharmaceutical company involved nothing more than the R&D of new...

Postmarket Assessment: Erythropoiesis Stimulators

By Yasuo Sugitani, MSc; Yukio Udagawa, BS; Shinichi Matsuda, MSc; Kana Yamada, MSc; Natsuko Miyawaki, MSc; Ichiro Konishi, MD, PhD, MBA Found in: Article, Safety & Pharmacovigilance

While benefit-risk (B-R) assessment in the real-world setting is an important challenge for pharmacovigilance, few studies...

New SIP Eases Investigators’ Burden

By Christine Pierre Found in: Article, Investigator Site, Clinical Research, Safety & Pharmacovigilance

In 2012, TransCelerate BioPharma Inc. was launched as a non-profit organization to improve the health of people around the world by…

Regulators Discuss BREXIT & Cancer Moonshot

Found in: Article, Regulatory Affairs, GMP, Public Policy / Law, Safety & Pharmacovigilance, Strategic Planning

One of the first DIA 2016 Annual Meeting DIAmond sessions, International Regulatory Convergence, Collaboration, and Cooperation…

Cost, Value, and Patient Outcomes: The Growing Need for Payer Engagement

By Gregory W. Daniel, PhD, MPH, RPh and Morgan H. Romine Found in: Pricing / Reimbursement, Public Policy / Law, Article, Clinical Supplies, Safety & Pharmacovigilance

Since passage of the Affordable Care Act in 2010, the last several years have seen a groundswell in physician payment and delivery reforms designed to achieve higher value health care through incentivizing higher quality care and lower overall costs.

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.

Global Forum Special Section: Orphan Drugs in the 21st Century

By Chris M. Slawecki Found in: Article, Safety & Pharmacovigilance, Clinical Research, Rare, Orphan Diseases

The US National Institutes of Health estimate that there are approximately 6,000 rare diseases affecting 25 million Americans. EURORDIS, the Voice of Rare Disease Patients in Europe, estimates the number of persons in Europe suffering from a rare disease at more than 30 million. Many of these conditions have no current treatment.

How to Prepare for a Safety Inspection

Development of a Clinical Study Report

Clinical Statistics for Nonstatisticians

Sheraton Boston Hotel

New Drug Product Development and Life Cycle Management

Sheraton Boston Hotel

Clinical Trial Disclosure and Data Transparency Conference

Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

DIA Global Center

Clinical Project Management

DIA Global Center

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

Biosimilars Conference

Hyatt Regency Bethesda

DIA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Combination Products Conference

Marriott Bethesda North Hotel

Adaptive Design in Clinical Trials: When and How to Apply

DIA Global Center

Pharmacovigilance and Risk Management Strategies Conference

Omni Shoreham Hotel

Regulatory Submissions, Information, and Document Management Forum

Bethesda North Marriott Hotel and Conference Center

DIA Webinar To Discuss How Technology and Collaboration Can Reinvent the Clinical Trial

Found in: Article, Clinical Research, Clinical Supplies, Safety & Pharmacovigilance, CMC

Many sponsor organizations are wrestling with how to improve the monitoring process with technology in an industry still fresh from the shackles of traditional paper-based data handling.