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Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. Global Harmonization Efforts There are ongoing efforts to harmonize bioequivalence standards and PSG-like documents across regulatory agencies worldwide.
In-depth presentation: The expert education session, conducted by Rajendra N. He explained the difference between incidents and deviations, stating that deviations are departures from written procedures, while incidents are unplanned events, reinforcing the need for clear SOPs and proper documentation.
Presentation Highlights: Balwinder Kaur provided an in-depth analysis of the Revised Schedule M, focusing on its strengthened pharmaceutical quality system requirements. Emphasising a proactive rather than reactive approach, she urged organisations to mitigate risks through thorough root cause analysis (RCA) and systematic documentation.
The patients mother noticed her sons left pupil was dilated and unresponsive to light the morning of presentation. Other documented pharmacological causes of anisocoria include nebulized ipratropium bromide and scopolamine (14-19). Physical Exam Vitals : BP 85/66; HR 143; RR 42; SpO2 100%; T 98.3F J Am Acad Dermatol. 2020;83(4):e275.
The session was led by A V Jayakumar, President- Quality, Ajanta Pharma Presentation highlights Jayakumar provided valuable insights from his extensive experience in quality management and regulatory compliance. He recounted his own experience working with investigative teams and the importance of being proactive when handling complaints.
Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.
He presented on good practices in quality control, highlighting the importance of appropriate qualifications and experience, and adequate facilities for storage and sampling. He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices.
Safety data in the studies were consistent with the well-documented safety profile of ILUMYA, which is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. No new safety signals were identified in the INSPIRE-1 and INSPIRE-2 studies.
.” She points out that, “Special attention is required when handling data related to children and minors, ensuring that verifiable consent is obtained from guardians and that consent management is robust and well-documented.
Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. ” – Dr. Vandana Shiva, Environmental Activist and Author Navigating the Patent Landscape for Natural Products Patenting natural products presents unique challenges. patent for the use of turmeric in wound healing.
Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards. Collaborative R&D models and partnerships also present an opportunity for Indian pharma companies to mitigate the risks and costs of innovation.
I formed the THRIV Coalition to champion bar code IV preparation technologies just as we had with administration technologies,” Neuenschwander said during his presentation. Watch the full presentation here and visit www.thrivcoalition.org to download the full checklist and learn more about how you can join advocacy efforts.
For those involved in late-stage drug development and manufacturing, this tailored approach could present both efficiencies and new technical expectations, particularly in the areas of analytical characterisation and data justification. Document 9286/25. Brussels: Council of the European Union; 2 June 2025.
Documentation – Ensure thorough, process-aligned SOPs and real-time CAPA management. The panel concluded that a phased, risk-based approach with clear documentation and management commitment is essential for successful compliance, particularly for MSMEs. Equipment – Prioritise automation and system upgrades for quality and efficiency.
history of present illness, physical examination, laboratory data), physicians employ a clinical reasoning process called "differential diagnosis" to weight the probability of one disease over other diseases that possibly account for the patient's signs and symptoms. Above the evidence-based professional recommendations on disease (i.e.,
history of present illness, physical examination, laboratory data), physicians employ a clinical reasoning process called "differential diagnosis" to weight the probability of one disease over other diseases that possibly account for the patient's signs and symptoms. Above the evidence-based professional recommendations on disease (i.e.,
Key recommendations include asking about undisclosed medication use in a non-judgemental way when patients present with symptoms such as dizziness or gastrointestinal issues. The document marks the first publication by the Obesity Management Collaborative UK, a professional network established in 2024 to support clinicians managing obesity.
Increasing due diligence efficiencies: Leveraging NLP and Gen-AI models to examine large volumes of documents in a data room for specific items of interest, reducing costs and analysis time of due diligence teams.
Whether it’s improving patient counseling or mastering SOAP note documentation, goal-setting helps you stay focused and measure progress throughout your APPE rotations pharmacy journey. Document Everything for Self-Evaluation and Career Growth Keep a rotation journal or digital log. Preceptors can become mentors and recommenders.
The FDA should require that sponsors document mechanisms for post-market surveillance, root-cause investigation of errors or malfunctions, and audit trails that track data inputs, model updates, and user interactions. Also important is the need for clearly defined and delineated accountability.
case presentation), be cautious about revealing names or other patient identifiers. Do not dispose of confidential documents and other media-containing sensitive information with regular waste. When discussing a patient with colleagues for patient care or training purposes (e.g. passwords for data stored electronically).
This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type.
Keep track of how often your system is being tested and how that testing is performed and documented. This blog post has been adapted from NABP’s presentation at the Asembia AXS25 Summit business session, Navigating the Accreditation Maze: Uncovering Common Deficiencies and Solutions.
Managing and integrating data from heterogeneous sources — such as genomic sequences, clinical data, biological images and chemical structures — presents a complex challenge in terms of data normalisation. Additionally, GenAI enhances clinical trial design by identifying eligible patients and shortening recruitment times.
Data are presented to allow the practitioner to understand the nuances considered when developing the dosing recommendations. The Renal Drug Handbook, 2019 The Renal Drug Handbook is an invaluable guide in which the information has been compiled from a wide range of sources and from the clinical experience of the UK Renal Pharmacy Group.
This article presents our consolidated perspective on the recurring challenges and deficiencies commonly encountered by Indian sterile drug manufacturing facilities, as observed through our engagements over the past eight years. Through our consulting engagements over the past eight years, RedLotus Pharmtech.
The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation. The proposed change also presents challenges to insurers, potentially undermining market stability.
From problem to progress: easing documentation burden One of the clearest examples of this mindset is how we approached provider burnout tied to EHR documentation. The results were clear: providers overwhelmingly preferred the AI scribe, and we saw meaningful reductions in documentation time and provider burnout.
This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type.
A retrospective study presented at the American Society of Health-System Pharmacists 2025 Pharmacy Futures meeting has revealed significant variability in asthma treatment regimens following initial diagnosis, with many patients not receiving care aligned with the Global Initiative for Asthma (GINA) recommendations. REFERENCES 1.
Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. Additional documents are included each month. 250 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms.
During a recent presentation hosted by Becker’s Healthcare, Thomas Kelly , MD, co-founder and CEO of Heidi Health outlined why conventional IT procurement models fail to deliver results with AI and what health systems must do differently to succeed. . By early 2024 , an estimated 70% of U.S.
Archive design basis documents for all facility, process, and utility decisions. Treat each deviation, complaint, or EM excursion as a rehearsal for an FDA discussion – document decisions, risk rationales, and CAPAs with inspection-grade clarity. Regularly conduct mock inspections using external or cross-site auditors.
SHOW MORE This abstract will be presented at the Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20, 2025. During this time frame, the pharmacy documented 152 interventions. Participants can present their work, exchange ideas, and connect with leaders in the field during these networking opportunities.
These developments present important opportunities to improve affordability and access— provided that the program is designed and implemented in a way that centers patient needs. https ://www.medpac.gov/document/june-2024-report-to-the- congress-medicare-and-the-health-care-delivery-system/. Joseph Mattingly II, Anthony A.
Pharmacy Times : Can you share what you presented at the 2025 OPC meeting? My role is really about using my expertise with medications to support decision-making based on data, like abstracts presented at meetings like this one, to ensure patients receive the best possible treatment.
It draws from patient information in the EHR to predict the appropriate level of care for each patient, presented through shared views of Xsolis’ proprietary Care Level Score™, which is updated in real-time. New generative AI features further assist clinical and revenue cycle teams by surfacing insights and streamlining documentation.
7015 FDA Advisory Committee Briefing Document: Columvi (glofitamab-gxbm) plus GemOx. Eligible participants were adults (≥ 18 years) with histologically confirmed R/R DLBCL who had received 1 or more prior systemic therapy and were deemed ineligible for autologous stem cell transplantation. month follow-up was 13.5 (7.9-18.5) J Clin Oncol.
Artificial intelligence (AI) platforms such as PGxAI are now automating literature review, guideline development, and reimbursement documentation, enabling pharmacogenetic innovation to move from discovery to clinical application in months rather than decades.
Opportunities Driving Adoption AI presents clear benefits for pharma marketers: 1. Documentation and Version Control : Keep detailed records of how AI content is created, reviewed, and approved. Human-in-the-Loop Processes : Require human review for all AI-generated content before publication.
Presentation Highlights: Dr J.P. The session concluded with a strong push for systematic documentation and continuous compliance vigilance in line with global GMP. He concluded by encouraging the industry to act decisively, as the future of Indian pharma depends on proactive compliance and commitment to excellence.
However, pay per click advertising (PPC) presents a powerful and targeted solution for pharma marketers looking to engage HCPs efficiently. Keep Detailed Records of PPC Campaigns Document ad approvals, compliance reviews, and campaign changes to maintain transparency in case of audits.
SHOW MORE When no contraindications are present, most cases can be managed well with nonsteroidal anti-inflammatory drugs. Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C.
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