The FDA Law Blog

NOVEMBER 1, 2022

Panelists discussed CMC challenges for CART therapies, including potency assay development, analytical method transfer, and demonstrating comparability. The majority of the workshop was spent on Q&A and included discussions on too many topics to write about in this blog. May help you avoid analytical bridging studies.

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FDA Process Improvement 59

ISPE

MAY 10, 2023

CoP Leader Profiles: Roujian “RJ” Zhang Trudy Patterson Wed, 05/10/2023 - 11:37 InTouch May / June 2023 CoP Leader Profiles: Roujian “RJ” Zhang Marcy Sanford 1 May 2023 Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. After I obtained my Ph.D.

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Method Validation FDA 52

pharmaphorum

SEPTEMBER 28, 2022

Harnessing Alternative Rapid Microbial Methods for a Successful Contamination Control Strategy. This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and increased regulatory stringency, to the latest technologies in rapid microbiological testing methods and data integrity.

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European Pharmaceutical Review

AUGUST 22, 2023

Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing. Digitalisation and automation Microndesign plans to develop new methods for optimising pharmaceutical freeze-drying processes for the manufacture of injectable drug products.

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Vaccines Packaging 87

pharmaphorum

DECEMBER 16, 2021

The two-day conference will explore the most pressing topics in this thriving field, from the movement toward process automation and minimisation of operator intervention, to the latest technologies in rapid microbiological testing methods and data integrity. Event Hashtag: #SMiPharmaMicroUK.

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Method Validation 52

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. However, some of the products manufactured in a topical drug facility can be difficult to clean. Lopolito Steven M.

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Method Validation Documentation Packaging Compounding 52

Pharmaceutical Technology

MAY 17, 2023

Both platforms use the company’s development, manufacturing and analytical capabilities in lentiviral vector (LVV) and adeno-associated viral vector (AAV). AGC Biologics’ proprietary procedure and capsid-based platform methods can speed up development timelines, thereby enabling the delivery of GMP products in nine months.

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ISPE

MAY 9, 2023

Cross-Fertilising Methodologies between Generation 1 (Gen 1) and Generation 2 (Gen 2) Products So, what are the common methodological enablers, potential cross-fertilising workflows, and good practices to apply these methods? In other words, do we have methods that allow cross-fertilisation? Yes indeed!

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Vaccines 98

Roots Analysis

AUGUST 20, 2023

Spectrometry is an analytical technique that is used to analyze the fundamental components of a radiation or ion beam’s spectrum. You can get more exhaustive INSIGHTS on this topic by reading the report summary published by Roots Analysis on the link here.

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Pharmaceutical Technology

AUGUST 17, 2022

Other capabilities include upstream processing in 2D flask and 3D bioreactor systems, downstream purification for attaining preferred purity and potency, as well as complete analytical characterisation of the resultant cell or exosome therapy that is formulated. . Topic sponsors are not involved in the creation of editorial content.

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Vaccines 52

The FDA Law Blog

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. lay users). This usually requires human factors or usability testing and labeling comprehension testing.

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FDA Labelling Hospitals 59

ISPE

MARCH 23, 2023

This blog post also seeks to provide discussion and guidance on some other topics related to “true copy” practices as below: The correct application of second person verification in the true copy process How to compliantly destroy original copies after verification of true copy. filling in a paper-based batch record or analytical result).

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Documentation FDA 98

The FDA Law Blog

SEPTEMBER 10, 2023

An interesting addition in the final guidance is that it explains that the topics discussed “apply to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA).” For obvious reasons, EUAs have been more prominent in recent years than they had been previously.

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FDA Documentation Vaccines 108

IDStewardship

AUGUST 1, 2023

As the second year of my master’s education was close, I was in a hurry to decide on the topic and method for my master’s thesis with my advisor (Dr. In other words, preliminary information was provided, methods were determined, and even implementations started. Unal and Dr. Inkaya.

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Hospitals Community Pharmacies Dosage Communication 212

ISPE

NOVEMBER 23, 2022

The Regulatory Challenges in ATMPs session provided a diverse set of perspectives on regulatory/quality topics as it pertains to late stage/commercial ATMPs, primarily autologous cell therapy.?The Melanie Eacho, Cell Therapies Branch Chief within the Office of Tissues and Advanced Therapies (OTAT) , US FDA/CBER.

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FDA Documentation 52

Roots Analysis

SEPTEMBER 1, 2023

New Drug Delivery Methods New drug delivery methods can help improve patient outcomes and reduce side effects, In addition, these methods can also increase patient adherence to medication regimens. You can also download the SAMPLE REPORT on this topic by Roots Analysis by clicking on the link here.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

European Pharmaceutical Review

JANUARY 29, 2024

6 The CPCA is a pragmatic, science-based approach which ensures that control strategies are more deliverable as method sensitivity/robustness considerations are more easily addressed. Conclusions Of the five major topics covered during 2023, it is likely that all will feature to a greater or lesser extent during 2024. 25 Sun et al.

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FDA Vaccines Compounding 97

Viseven

MAY 15, 2023

With the advent of digital marketing, plenty of new forms of online communication emerged and eventually superseded detailing that turned from the most fundamental method of engagement into one of many. HCPs can share their professional and personal opinions on the brand, products, or any other e-detailing topic with a drug company.

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Pharmaceutical Companies Pharmaceutical Companies Communication Patient Care 52

The FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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FDA Labelling 59

ISPE

JULY 21, 2023

The seminar was organized with opening keynote and plenary presentations followed by three tracks, one for each of the above topics with closing plenary sessions. Prior to this she was at Genentech Roche for 17 years in various global roles in Product Development, Quality, QC and Analytical Sciences.

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Documentation 98

pharmaphorum

NOVEMBER 23, 2022

I haven’t presented; I’m here mainly as the business team for some of our professional clients, but also partners as part of that topic, also. A lot within the conference agenda and presentation has been around outcomes, thinking about value and holistic methods and how to move that more from the commercial end.

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Dosage Documentation Hospitals Vaccines 98

ISPE

NOVEMBER 3, 2022

A white paper on regulatory development for low- to middle-income countries, international collaboration on methods for producing gene therapies, and public/private partnerships to support therapies for extremely rare disorders are other steps to consider. method of manufacture and analysis), and accept some variability in other areas?

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Communication FDA Documentation Vaccines 98

Pharmaceutical Technology

JUNE 15, 2023

These patterns might reveal trends that would be difficult or impossible to detect using traditional methods. The platform allows employees to easily connect with subject matter experts that can share past experiences and provide support for a specific topic.

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Compounding Adverse Reactions Dosage Documentation 52

European Pharmaceutical Review

FEBRUARY 23, 2023

Given the widely reported challenges of validation and qualification of microbiological methods, as well as lab compliance and keeping up with compendial amendments, I have steered away from these topics here. However, firms must establish if or how these platforms diverge from compendial methods and possible failure modes.

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Dosage Vaccines 95

PharmaShots

MARCH 6, 2023

Our biologists are now working side-by-side with data scientists to combine the data with computational methods – instead of manually collecting data, we are using Microsoft technology to create huge knowledge graphs in an unattended or automated manner. Clinical trials are a key topic for these interactions.

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Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

IDStewardship

JUNE 5, 2023

To shed light on this important topic, we had the privilege of interviewing an esteemed expert [ChatGPT by OpenAI] in the field of antimicrobial stewardship. This automation can save time and resources compared to manual surveillance methods, allowing stewardship programs to detect and respond to issues promptly.

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Vaccines Hospitals Patient Care 234

European Pharmaceutical Review

JANUARY 16, 2023

Another major topic covered by the experts was technological advances. Cellular products directed towards personalised medicine have short manufacturing cycles, small batch sizes, demanding analytical methods, and short shelf lives. I think we’ll see our labs change significantly over the next five to 10 years.

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Vaccines FDA Research Laboratories Documentation 126

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Documentation Method Validation Packaging 88

ISPE

MAY 25, 2023

™ is the concept of ‘Plug and Produce’ connectivity, with a dedicated team on this topic led by Wolfgang Winter, and this part of the session will go on to provide practical insights on Pharma 4.0™ ISPE members can join the ongoing PAT journey in the ISPE Engage forum Process Analytical Control & Lifecycle Strategy. The Pharma 4.0™

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FDA 96

ISPE

JULY 19, 2023

Working groups were created for the following topics: impact and maturity models, plug and produce, continuous process verification (CPV) and process automation, process maps and critical thinking, holistic digital enablement, validation 4.0, Figure 5: Analytical and logistical solutions created on eData platforms. ™ (Figure 3).

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Documentation FDA Labelling Communication 98

ISPE

NOVEMBER 10, 2022

I focus my work to improve the required methods, equipment, and systems for our emerging industry to scale to meet our vision. We are missing data in the required formats to apply advanced analytics on significant parameters and from QC data that would aid us to continuously optimize the product and process over time.

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Documentation Compounding Hospitals Immunization 98

Pharmaceutical Technology

MAY 10, 2023

Particle analysis on a micro-scale is a significant topic in several fields of application. IR microscopy for easy analysis of fibres, particles and residues There are several methods used for particle analysis, with each one having its own specialities and being suited to different applications.

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The Social Pharmacist

AUGUST 17, 2022

In this article, we’ll show you how to interpret your bounce rate and five proven methods for lowering it down to increase conversions. Also, it means that the Google Analytics server doesn’t receive a trigger from the visitor. 7 Quick and Easy Methods to Reduce Bounce Rate. Use Google Analytics to Calculate Bounce Rate.

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Independent Pharmacies 52

The Social Pharmacist

AUGUST 17, 2022

7 Proven Methods to Reduce Bounce Rate on Your Pharmacy Website. In this article, we’ll show you how to interpret your bounce rate and five proven methods for lowering it down to increase conversions. Also, it means that the Google Analytics server doesn’t receive a trigger from the visitor. Bounce Rate in a Pharmacy Website.

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Independent Pharmacies 40

PharmaShots

FEBRUARY 27, 2023

Mr. Mekala Rao The topic discussed by Mr. Mekala was Metaverse: Healthcare and its role in this Game changing Technology. Session 2: Panel Discussion Topic: Advanced Manufacturing Technologies Moderator: Ms. So, people have neglected it that’s what I would say.” The token of appreciation was then given to each speaker.

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Packaging Hospitals FDA Pharmaceutical Companies 40

The FDA Law Blog

OCTOBER 6, 2022

OTP acknowledged the elephant in the room that their expectations for comparability assessment is a “hot topic”, and that to address this complex question, they are developing a specific guidance document (i.e., In addition, they should know how to control for analytical method variability prior to starting the clinical trial.

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Documentation FDA Communication 52

Roots Analysis

SEPTEMBER 20, 2023

Novel techniques , like chromatographic methods in parallel with UV spectrometric analysis improve the overall accuracy and sensitivity of the analytical assays. You can also download the SAMPLE REPORT on this topic by Roots Analysis by clicking on the link Cannabis Testing Market.

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