Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 15-15
Author(s):  
David Michael Waterhouse ◽  
Caleb Burdette ◽  
Dan Davies ◽  
David R. Drosick ◽  
Molly Mendenhall

15 Background: Biosimilars are clinically equivalent and highly similar to brand yet cost significantly less. Financial savings are shared by patients, practices and payers, ranging anywhere from 21-24% based on 10/01/20 ASP data from CMS. The effective conversion to biosimilar products is vitally important to total cost-of-care savings and can be achieved without negatively affecting patient outcomes. Physician understanding and confidence in biosimilar products is seen as a major conversion barrier. Methods: Interchangeability is an FDA designation that allows generic drugs to be substituted for reference drugs at the pharmacy, without a physician’s consent. Currently no biosimilar has that FDA approval for interchangeability. Building on previous pharmacy auto-substitution processes with therapeutic interchange, a formalized biosimilar policy and SOP was developed to automate conversion from the reference biologic product to the P&T/Physician approved biosimilar. Workflow changes were instituted to alleviate the provider burden of patient-by-patient decisions and placed them with the pharmacy review team. Full staff support and understanding on biosimilar usage was endorsed through mandatory biosimilar education of physicians, advanced practice providers, pharmacists, nurses, financial navigators and prior authorization team members and tracked using meeting attendance and the online E-learning system. Patient education was verified using established teaching visits by tracking documentation in the electronic health record (EHR). Quantitative metrics and reports were developed to assist in tracking the number of unique patients receiving the brand or biosimilar agents. Billed product units per month were also tracked to facilitate auditing and assure accuracy. Baseline brand/biosimilar utilization data for Rituximab, Trastuzumab, and Bevacizumab was collected from July 1, 2019 through December 31, 2020. Results: During the baseline period of 7/01/19 – 12/31/19, biosimilar conversion ranged from 0% (trastuzumab) to 8.4% (rituximab). Following full staff education and physician consent, systematic auto-conversion to biosimilar products was initiated on January 1, 2020. Conversion rates based upon billed biosimilar units likewise improved from 11.7% (baseline) to 90.2% (2021 Q1) for rituximab, 8.4% to 87.4% for trastuzumab, and 0% to 90.0% for bevacizumab. Conclusions: Rapid and near-complete conversion from brand product to FDA approved biosimilar is feasible, measurable and can be scaled.[Table: see text]


Author(s):  
Catherine Boden ◽  
Marie T. Ascher ◽  
Jonathan D. Eldredge

Objectives: The Medical Library Association (MLA) Systematic Review Project aims to conduct systematic reviews to identify the state of knowledge and research gaps for fifteen top-ranked questions in the profession. In 2013, fifteen volunteer-driven teams were recruited to conduct the systematic reviews. The authors investigated the experiences of participants in this large-scale, volunteer-driven approach to answering priority research questions and fostering professional growth among health sciences librarians.Methods: A program evaluation was conducted by inviting MLA Systematic Review Project team members to complete an eleven-item online survey. Multiple-choice and short-answer questions elicited experiences about outputs, successes and challenges, lessons learned, and future directions. Participants were recruited by email, and responses were collected over a two-week period beginning at the end of January 2016.Results: Eighty (8 team leaders, 72 team members) of 198 potential respondents completed the survey. Eighty-four percent of respondents indicated that the MLA Systematic Review Project should be repeated in the future and were interested in participating in another systematic review. Team outputs included journal articles, conference presentations or posters, and sharing via social media. Thematic analysis of the short-answer questions yielded five broad themes: learning and experience, interpersonal (networking), teamwork, outcomes, and barriers.Discussion: A large-scale, volunteer-driven approach to performing systematic reviews shows promise as a model for answering key questions in the profession and demonstrates the value of experiential learning for acquiring synthesis review skills and knowledge. Our project evaluation provides recommendations to optimize this approach.


2010 ◽  
Vol 2 (4) ◽  
pp. 604-609 ◽  
Author(s):  
Kathryn M. Andolsek ◽  
Alisa Nagler ◽  
Leslie Dodd ◽  
John L. Weinerth

Abstract Background The Accreditation Council for Graduate Medical Education (ACGME) mandates that sponsoring institutions conduct internal reviews. In 1998, the ACGME Institutional Review Committee gave Duke University Hospital a citation for an inadequate internal review (IR) process. Since then, we have instituted several iterative changes. We describe the evolution of Duke University Hospital's current internal review process. Intervention We implemented a new review team composition, template report, use of the program information form, and centralization of documentation to improve our internal review process. In 2007, a more formal evaluation of the outcome and impact of these changes was instituted. This included a yearly survey of all participants and review team members, a review of programs, and a tracking process for the decisions of our Graduate Medical Education Committee (GMEC) on the status of reviewed programs. Results Participants from both the program under review and the review team evaluated the process favorably. Review teams reported they learned from the best practices of the program being reviewed. Program directors from the reviewed programs reported the process improved their documentation. Both groups reported the process better prepared them for their next ACGME Review Committee site visit. The GMEC has recommended “probationary sponsorship” for fewer programs since the IR process changes have been implemented. The IR process was recognized as a best practice in Duke University Hospital's 2004 ACGME institutional review. Conclusion We believe our IR process, review-team composition, template report, program information form, and centralized documentation now fully meets accreditation standards. Participants are reasonably satisfied and report value from the process. More programs are judged to be within substantial compliance by the GMEC.


1992 ◽  
Vol 18 (1) ◽  
pp. 18-23 ◽  
Author(s):  
Brian Enright ◽  
Richard White ◽  
Kay F. Haney ◽  
H. William Heller ◽  
Fred Spooner

Co-editors, Associate Editors, and Cohort Review Team members for Teaching Exceptional Children were asked to nominate qualified individuals to identify seminal articles in the area of behavioral disorders. The nominees identified in this first phase of the study recommended the top 19 classic contributions in behavioral disorders. In the second phase of the study, a self-identified panel of 172 persons in the area of behavioral disorders rank ordered these 19 classic works. Results are discussed in relation to another study that examined seminal contributions in the broader area of special education and in relation to the history of behavioral disorders.


Author(s):  
Shun Takai ◽  
Marcos Esterman

Cooperation among team members and good teamwork are essential to successfully complete design projects. As such, engineering students are expected to learn how to design and work effectively in a team. While, team-based project courses have been implemented in almost all engineering and engineering technology disciplines, achieving full contribution by all team members has been a persistent challenge in design and other engineering disciplines. This paper proposes a possible approach to establish guidelines to form design teams. In this paper, we first review team-effectiveness models. We then propose a design-team-effectiveness model, which will study associations between inputs, processes, and outputs in order to improve team processes and maximizes team performance through design team composition, work structure and improved team processes. Finally, we propose (1) measurements of design-team inputs, processes, and outputs, and (2) approaches to analyze associations among inputs, processes, and outputs.


2021 ◽  
Author(s):  
Olyvia Donti ◽  
Andreas Konrad ◽  
Ioli Panidi ◽  
Petros Dinas ◽  
Gregory Bogdanis

Review question / Objective: To examine if there is a difference in the effect of stretching training on flexibility during childhood (6-11 years of age) and adolescence (12-18 years of age). Condition being studied: We are going to examine whether there is a greater response to stretching training (i.e. ‘window of opportunity’) during childhood, compared with adolescence. Information sources: Two review team members will independently screen the titles and abstracts of the retrieved publications to select the eligible publications. One review team member will act as a referee in case of disagreement between the review team members. We will also ensure that any retracted publications are identified and excluded from the selection outcome. Furthermore, we will locate the full texts that will not be immediately accessible, via emails to the lead authors and/journals of publication. A full list of the excluded publications will be provided in the final version of the systematic review.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anna H. Noel-Storr ◽  
Patrick Redmond ◽  
Guillaume Lamé ◽  
Elisa Liberati ◽  
Sarah Kelly ◽  
...  

Abstract Background Crowdsourcing engages the help of large numbers of people in tasks, activities or projects, usually via the internet. One application of crowdsourcing is the screening of citations for inclusion in a systematic review. There is evidence that a ‘Crowd’ of non-specialists can reliably identify quantitative studies, such as randomized controlled trials, through the assessment of study titles and abstracts. In this feasibility study, we investigated crowd performance of an online, topic-based citation-screening task, assessing titles and abstracts for inclusion in a single mixed-studies systematic review. Methods This study was embedded within a mixed studies systematic review of maternity care, exploring the effects of training healthcare professionals in intrapartum cardiotocography. Citation-screening was undertaken via Cochrane Crowd, an online citizen science platform enabling volunteers to contribute to a range of tasks identifying evidence in health and healthcare. Contributors were recruited from users registered with Cochrane Crowd. Following completion of task-specific online training, the crowd and the review team independently screened 9546 titles and abstracts. The screening task was subsequently repeated with a new crowd following minor changes to the crowd agreement algorithm based on findings from the first screening task. We assessed the crowd decisions against the review team categorizations (the ‘gold standard’), measuring sensitivity, specificity, time and task engagement. Results Seventy-eight crowd contributors completed the first screening task. Sensitivity (the crowd’s ability to correctly identify studies included within the review) was 84% (N = 42/50), and specificity (the crowd’s ability to correctly identify excluded studies) was 99% (N = 9373/9493). Task completion was 33 h for the crowd and 410 h for the review team; mean time to classify each record was 6.06 s for each crowd participant and 3.96 s for review team members. Replicating this task with 85 new contributors and an altered agreement algorithm found 94% sensitivity (N = 48/50) and 98% specificity (N = 9348/9493). Contributors reported positive experiences of the task. Conclusion It might be feasible to recruit and train a crowd to accurately perform topic-based citation-screening for mixed studies systematic reviews, though resource expended on the necessary customised training required should be factored in. In the face of long review production times, crowd screening may enable a more time-efficient conduct of reviews, with minimal reduction of citation-screening accuracy, but further research is needed.


1986 ◽  
Vol 17 (3) ◽  
pp. 230-240 ◽  
Author(s):  
Lou Tomes ◽  
Dixie D. Sanger

A survey study examined the attitudes of interdisciplinary team members toward public school speech-language programs. Perceptions of clinicians' communication skills and of the clarity of team member roles were also explored. Relationships between educators' attitudes toward our services and various variables relating to professional interactions were investigated. A 64-item questionnaire was completed by 346 randomly selected respondents from a two-state area. Classroom teachers of grades kindergarten through 3, teachers of grades 4 through 6, elementary school principals, school psychologists, and learning disabilities teachers comprised five professional categories which were sampled randomly. Analysis of the results revealed that educators generally had positive attitudes toward our services; however, there was some confusion regarding team member roles and clinicians' ability to provide management suggestions. Implications for school clinicians were discussed.


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