Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies

By Gary L. Steinman, MSE; William B. Smith, MD; Mary L. Westrick, PhD; Howard E. Greenberg, MD Found in: Article, Safety & Pharmacovigilance, Clinical Trial Disclosure

This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016...

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.

Biosimilars Conference

Hyatt Regency Bethesda

Special Populations in Clinical Pharmacology Studies Evolving Challenges

By William B. Smith, MD; Harry Alcorn, PharmD Found in: Article, Safety & Pharmacovigilance, Clinical Research, Clinical Trial Disclosure

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Safety in FIH Trials A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost”

By Howard E. Greenberg, MD; Mattheus (Thijs) van Iersel, MD; Mary L. Westrick, PhD; William B. Smith, MD Found in: Article, Safety & Pharmacovigilance, Clinical Research

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in...

Combination Products Conference

Bethesda North Marriott Hotel and Conference Center

The Impact of Innovation - How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework

By Michael Doherty, DMS; Nancy Bradish Myers, JD; Anne Petruska McNickle, BA Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Data Management / eClinical, Safety & Pharmacovigilance

Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks...

Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies

By Gary L. Steinman, MSE; William B. Smith, MD; Mary L. Westrick, PhD; Howard E. Greenberg, MD Found in: Article, Safety & Pharmacovigilance, Clinical Trial Disclosure

This paper summarizes a discussion that took place at the 52nd Annual DIA Meeting in Philadelphia, PA, on June 30, 2016...

Special Populations in Clinical Pharmacology Studies Evolving Challenges

By William B. Smith, MD; Harry Alcorn, PharmD Found in: Article, Safety & Pharmacovigilance, Clinical Research, Clinical Trial Disclosure

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase...

Safety in FIH Trials A Summary of the Symposium “Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost”

By Howard E. Greenberg, MD; Mattheus (Thijs) van Iersel, MD; Mary L. Westrick, PhD; William B. Smith, MD Found in: Article, Safety & Pharmacovigilance, Clinical Research

A cross-section of clinical research professionals convened at the June 2016 Drug Information Association annual meeting in...

The Impact of Innovation - How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework

By Michael Doherty, DMS; Nancy Bradish Myers, JD; Anne Petruska McNickle, BA Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Data Management / eClinical, Safety & Pharmacovigilance

Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks...

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.

Social Media & Safety Without Borders

By Elena Popa, Junior Scientist, DIA EMEA Found in: Article, Safety & Pharmacovigilance, Medical Communications

Mobile apps and social media are within everyone’s reach, no matter your age or where you’re from. Their potential for good and…

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...

The Enigma of Pharmacovigilance of Patient Support Programs

By Jamie Michelle Portnoff, BS; David John Lewis, BSc (Hons), PhD Found in: Article, PE / Quality of life / Health, Safety & Pharmacovigilance

Pharmacovigilance of patient support programs (PSPs) has been the subject of debate, legislation, and guidance, and regulatory...

Innovation in Medical Evidence Development and Surveillance (IMEDS)

By June S. Wasser Found in: Article, Safety & Pharmacovigilance

The Innovation in Medical Evidence Development and Surveillance (IMEDS) Program, modeled after the Sentinel Initiative...

Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Sheraton Philadelphia University City

Biosimilars Conference

Hyatt Regency Bethesda

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Bethesda North Marriott Hotel and Conference Center

Combination Products Conference

Bethesda North Marriott Hotel and Conference Center

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

Advertising and Promotion Regulatory Affairs Conference

Bethesda North Marriott Hotel and Conference Center

Medical Affairs and Scientific Communications Forum

Omni Las Ranchos Palmas Resort & Spa

Advanced Signal Detection

DIA Global Center

Biostatistics Industry and Regulator 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.