Mistake-Proofing the Workplace
By Zachary Sherman, Max Sherman -
Published 22 September 2017
This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.
Categories: Features, Compliance, Manufacturing, Quality
Tags: Errors, Defects, Quality
France Reimbursement Profile
By Jenifer Ehreth, MHA, PhD -
Published 20 September 2017
This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.
Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement
Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France
England Reimbursement Profile
By Vishal Patel -
Published 18 September 2017
This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process.
Categories: Features, Europe, MHRA, NICE, Biologics and biotechnology, Drugs, Reimbursement
Tags: NICE, NHS, Reimbursement
Italy Reimbursement Profile
By Patrizia Berto, PharmD, MBA -
Published 14 September 2017
This profile summarizes the reimbursement process in Italy, presents key stakeholders and highlights what should be considered early in the development process.
Categories: Features, Europe, EMA, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement
Tags: AIFA, Agenzia Italiana del Farmaco, Reimbursement
FDA Draft Guidance for Medical Product Communications
By Alan Bergstrom -
Published 13 September 2017
This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."
Categories: Features, FDA, Communication, Labeling
Tags: Communication, Labeling
Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies
Published 08 September 2017
In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.
Categories: Features, US, FDA, Biologics and biotechnology, Human cell and tissue, Reimbursement
Tags: Regenerative Medicine, ARM, Michael Werner, Ted Slocomb
Health Technology Assessment, Reimbursement, Scientific Research, Risk Management, Generic Drug Legislation and a Preview of September
By Gloria Hall -
Published 06 September 2017
The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in September.
Categories: Features, FDA, Health Canada, Biologics and biotechnology, Generic drugs, Medical Devices, Regulatory strategy, Reimbursement
Tags: Regulatory Focus, Feature Articles, Editorial
Drug Reimbursement in Canada
By George Wyatt, MBA -
Published 01 September 2017
This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.
Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Reimbursement
Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review
Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes
By Dr Elin Haf Davies, Chris Tyson -
Published 28 August 2017
This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.
Categories: Features, FDA, Medical Devices
Tags: Wearables, Mobile Health, mHealth, Patient Reported Outcomes
The Value of Health Technology Assessment Scientific Advice
By Amina Udechuku, PhD, Matthew William Bending, PhD, MSc -
Published 23 August 2017
In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.
Categories: Features, Canada, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs
Tags: Health Technology Assessment, HTA
Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices
By Mark Domyahn -
Published 21 August 2017
This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy.
Categories: Features, US, FDA, Medical Devices, Reimbursement
Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage
Bioequivalence Studies of Solid Oral Dosage Forms Overview
By Sharry Arora -
Published 16 August 2017
The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.
Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs
Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability
Organizational Culture and Memory in Managing Risk in the Medical Device Industry
By Darin Oppenheimer, DRSc, Suraj Ramachandran, MS, RAC -
Published 15 August 2017
This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."
Categories: Features, US, FDA, Business Skills, Medical Devices
Tags: Risk Management, Organizational Culture
Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality?
By Max Sherman -
Published 14 August 2017
This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.
Categories: Features, FDA, Biologics and biotechnology
Tags: Bacteriophage, Phage, Antimicrobial Resistance
Regulatory Career Paths and Progression, Resources and Training, FDA Inspections, Cleaning Validation and a Preview of August
By Gloria Hall -
Published 01 August 2017
Feature articles over the past several weeks highlighted regulatory affairs as a profession, including careers in regulatory advertising and promotion, possible pathways and career progression and resources and training for regulatory professionals. Other articles covered various types of inspections conducted by FDA and processes for cleaning validation in the pharmaceutical industry.
Categories: Features, Career Development
Tags: Features, Regulatory Focus
A View From the Top: An Interview with CRI President Jennifer Kerr, RAC
By Mary Faderan, PhD, RAC -
Published 31 July 2017
This article is based on an interview with Cook Research Incorporated (CRI) president Jennifer Kerr and covers a wide range of topics from her education, to how she became interested in regulatory, to her experiences in clinical affairs and her responsibilities at CRI.
Categories: Features, Career Development, Communication
Tags: Interview, RAC
Resources and Training for Regulatory Professionals
By Sofia Campos Silva, MSc, PharmD -
Published 27 July 2017
This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.
Categories: Features, Business and Leadership, Career Development, Regulatory intelligence
Pharmaceutical Cleaning Processes
By John Godshalk, MSE, MBA -
Published 26 July 2017
This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.
Categories: Features, FDA, WHO, Drugs
Tags: Cleaning, Washing, Rinsing, Cleaning Validation
Ten Secrets to Regulatory Success
By Jody J. Savage, MS, MBA -
Published 20 July 2017
This article highlights "10 secrets to success" for regulatory professionals that may not be taught in formal regulatory affairs training programs, but practices the author learned "on the job." It includes suggestions for developing regulatory submissions and the importance of good writing, doing your "homework" and systematizing work procedures.
Categories: Features, Career Development, Communication
Careers in Regulatory Advertising and Promotion
By Dana Huettenmoser, PharmD -
Published 19 July 2017
This article provides an overview of Regulatory Advertising and Promotion (RAP) as a career in the pharmaceutical industry and discusses topics such as potential avenues for starting a career in RAP, qualities required to be successful, and some general career advice, including information on post-PharmD RAP fellowships and the benefits to be gained from serving them.
Categories: Features, Advertising and Promotion, Career Development
Regulatory Career Progression
By Kamila Kawiak, Kavita Patel -
Published 17 July 2017
This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.
Categories: Features, Business and Leadership, Career Development, Career Search
Tags: Career Development, Regulatory Profession
FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities
By Sharry Arora -
Published 14 July 2017
The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).
Categories: Features, US, FDA, Compliance, Drugs, Manufacturing
Tags: Oral Solid Dosage, OSD, Inspections
Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July
By Gloria Hall -
Published 05 July 2017
Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.
Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration
Tags: Regulatory Focus, Feature Articles
Medicinal Product Registration in Egypt
By Shweta Menon -
Published 26 June 2017
This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market.
Categories: Features, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration
Tags: EDA, Egyptian Drug Authority
Syphilis: a Mysterious and Serious Ancient Disease
By Max Sherman -
Published 13 June 2017
This article alerts regulatory professionals to the continued presence of what may be a "forgotten" disease–syphilis. Although syphilis is unique and may be considered a "relic" of the past, it does not belong in the dust bin of history. To the contrary, regulatory professionals may wish to know more about its controversial medical history, epidemiology and clinical manifestations as syphilis remains a serious public health threat in many parts of the world. These issues in addition to the possible serious consequences of untreated syphilis provide a clear rationale for developing a vaccine.
Categories: Features, Drugs