Teaching: An Integral Responsibility for Regulatory Professionals
Effective teachers make a significant difference in student achievement. Online courses are no substitute. Interaction with a trainer allows ideas to be exchanged freely and without communication barriers. Qualified teachers help learners make fewer mistakes and, thus, reduce the likelihood of errors in the workplace. Tips on class preparation, presentation, assessment and follow-up for regulatory professionals who must all, at some point, be teachers.
Categories: Features, Business and Leadership, Communication
Posting Public Comments Can Increase Consumer Engagement with FDA
An argument that timely online posting by the US Food and Drug Administration of all public comments submitted by individual consumers would increase public engagement and align well with other efforts by the agency to facilitate public input about policy issues.
Categories: Features, US, FDA, Communication
CROs: Selecting and Managing Contract Regulatory Development Resources
CROs have emerged as critical partners in drug development, whether they offer comprehensive or focused services. This partnership requires effective integration of internal and external processes and programs that are managed proactively.
Categories: Drugs, Project management, Features
Out of Africa: Six Regulatory Articles that Span the Continent
Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.
Categories: Drugs, Government affairs, Project management, Submission and registration, Features, Africa
Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante
Outsourcing Pharmacovigilance in Small Pharmaceutical Companies: A Perspective
A look at the blended approach and other options for an outsourced pharmacovigilance model and their benefits for small pharmaceutical companies. This article provides advice on the steps required to complete a successful PV outsourcing project.
Categories: Drugs, Project management, Features
Outsourcing: Not My Problem?
The vast majority of outsourcing decisions affect regulatory submissions/applications and pharmacovigilance to varying degrees. Therefore, outsourcing should be of considerable interest to regulatory professionals. By making outsourcing issues their concern, regulatory professionals can ensure it is not a problem.
Categories: Drugs, Project management, Regulatory strategy, Features
Pharmaceutical Outsourcing: A Korean Perspective
Background on the South Korean pharmaceutical industry and how companies select and choose suppliers and contractors, including regulatory affairs or regulatory compliance consultants or providers.
Categories: Drugs, Regulatory strategy, Features, Korea
Regulatory Focus Recap: January 2015
A recap of Regulatory Focus feature articles published in January 2015 for your reading convenience.
Categories: Drugs, In vitro diagnostics, Medical writing, Preclinical, Features
South Africa Medicines Regulatory System Overview
South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.
Categories: Drugs, Government affairs, Submission and registration, Features, Africa
Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier
Writing Skills for the Regulatory Professional
Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. This article is an introductory overview of his upcoming book and demonstrates that strong writing skills are a core competency of regulatory professionals.
Categories: Medical writing, Project management, Features, Communication
Tags: writing skills, technical writing, writing training
'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer
A flexible training methodology, referred to as the "cafeteria-style" approach, provides effective, efficient instruction for onboarding regulatory technical writers. This style of training is also useful in providing ongoing professional development for current staff.
Categories: Medical writing, Project management, Features, Communication
Tags: regulatory writing, training, regulatory technical writers, training buckets
Writing Regulatory Documents with E-Submissions in Mind
Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated. This article offers some practical tips to help authors prepare regulatory documents in a more efficient manner, which can shorten submission timelines and save resources.
Categories: Medical writing, Project management, Submission and registration, Features
Tags: electronic submissions, cross-referencing, hyperlinks, eCTD, templates, style guides, leaf titles
Types of In Vitro Diagnostics: Clearing Up the Confusion
In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.
Categories: In vitro diagnostics, Features, US, FDA
Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA
Integrated Summaries of Effectiveness and Safety: Writing in the Context of the CTD
Two common approaches to writing Integrated Summaries of Effectiveness and Safety (ISE and ISS, respectively) and the Summaries of Clinical Efficacy and Safety are discussed, with the focus based on medical writers’ experience with document preparation for a US NDA or BLA. However, given that the Common Technical Document (CTD) format is accepted in the US, the EU and Japan, the same strategies also can be applied to those regions.
Categories: Biologics and biotechnology, Drugs, Medical writing, Submission and registration, Features, US, FDA
China FDA 'Flying Inspections' for Drugs: How They Work
The China Food and Drug Administration conducts special drug manufacturing inspections without advanced notice. These so-called “flying inspections” are in addition to regular GMP inspections. The article provides a summation of the key elements of CFDA’s proposed flying drug regulation, including its objective, scope, inspectors’ responsibilities and process.
Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, Features, China, CFDA, APIs
Fruit Flies––Powerful Foot Soldiers in Genetic Research
Fruit flies have revolutionized biological science since their research use began in earnest in the early 20th century. Some recent studies using fruit flies may have an impact on treatments for alcoholism, drug abuse, neurological and behavioral diseases, sleep, tumors and diabetes.
Categories: Drugs, Preclinical, Research and development, Features
Tags: Fruit flies, Drosophila, research, genetics, history
Northern Africa: Regulatory Submission Considerations for the Region
Northern Africa is an emerging region presenting unique regulatory submission considerations. Although sponsors usually seek to re-use key portions of a submission dossier to apply for approval in multiple Northern African countries, each national regulatory authority maintains specific regulations and procedures.
Categories: Drugs, Distribution, Regulatory strategy, Submission and registration, Features, Africa, FDA, EMA, WHO
Tags: Africa, Northern Africa, regulatory submissions, Western Sahara, Mauritania, Morocco, Algeria, Tunisia, Libya, Egypt, Sudan
Canada and the Orphan Drug Framework--Where Are We Now?
Canada is in the final stages of developing an orphan drug policy for drugs affecting populations of 5 in 10,000 people. Bill C-17 has passed the legislature and is awaiting final approval. The new policy will then be open for comment. Fee mitigation, accelerated review and HTA collaboration are incentives but marketing exclusivity is not, although discussions on that topic are taking place. The final hurdle is provincial and private payment plans.
Categories: Prescription drugs, Orphan products, Government affairs, Reimbursement, Features, Canada, FDA, EMA, Health Canada
Tags: orphan drugs, Bill C-17, Vanessa's law, payment plans
Applying Ethics to Conflicting Healthcare Philosophies: The Ebola Example and the RAPS Ethics Code
How regulatory professionals can apply the RAPS Code of Ethics to current and future endemic disease outbreaks characterized by a rapidly developing healthcare situation and quickly evolving knowledge base regarding prevention, treatment and potential cures.
Categories: Drugs, Ethics, Features, Africa
Tags: Ebola, emerging diseases, treatments, prevention, potential cures
US Orphan Drug Exclusivity Criteria Clarified in Depomed Court Decision
Key points and observations about a recent federal court decision on orphan drug exclusivity as outlined in the case of Depomed v. US. The central issue concerned what conditions a drug must satisfy to qualify for marketing exclusivity.
Categories: Generic drugs, Orphan products, Features, US
Tags: Depomed v US, orphan drugs, Neurontin, Gralise, post-herpetic neuralgia, exclusivity, clinical superiority
The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)
A two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.
Categories: Drugs, Distribution, Submission and registration, Features, Asean
Tags: ASEAN, pharmaceuticals, Asian markets, regulatory review, Singapore, Malaysia, Thailand, Philippines, Indonesia, harmonization
RCOREs: African Regional Centres of Regulatory Excellence
African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 10 RCOREs throughout Africa. Their goal is to strengthen regulatory capacity development by providing academic and technical training in regulatory science.
Categories: Government affairs, Features, Africa
Tags: Africa, AMRH, RCOREs, regional centres of excellence, regulatory training
US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know
The US FDA Unique Device Identification final rule dictates when submissions must be made to the GUDID database. There are four methods to submit the device record. What are the key considerations for future GUDID submissions and how may device manufacturers keep their options in mind?
Categories: Medical Devices, Compliance, Features, US, FDA
Tags: US, FDA, UDI, GUDID, medical devices, regulations, Global Unique Device Identification Database
Tumor Paint—A Novel Approach to Enhance Surgical Resection
An experimental imaging agent dubbed "tumor paint" could help surgeons resect tumors with the least amount of damage to surrounding healthy tissues. The tumor paint is being studied in gliomas, among the deadliest forms of cancer.
Categories: In vitro diagnostics, Research and development, Features, FDA
Asia Regulatory Roundup: Status Quo for Indian Trials; TGA Inspections Lag (11 November 2014)
Welcome to our Asia Regulatory Roundup, a new feature exclusively for RAPS members. Each week our roundup will provide you with the latest, most important regulatory news affecting Asia and the companies operating therein. This week's top news includes Australia's struggle to inspect foreign and domestic drug manufacturing facilities and India's about-face on a reported clinical trials proposal.
Categories: Regulatory intelligence, News, China, India, Oceania, CFDA, CDSCO, TGA
Tags: Asia Regulatory Roundup, Regulatory Roundup