ACRP blog

JANUARY 11, 2024

As the saying goes, “With great power comes great responsibility,” and with so many clinical study site leaders now taking technological powers into their hands that were traditionally held by sponsors, some of them and their staff may be surprised to find the awesome responsibilities that come packaged with the deal. View complete schedule.

Compliance 59

Compliance Regulation Packaging Packaging 59

Cloudbyz

MARCH 3, 2023

Regulatory Compliance Compliance with regulatory requirements is critical for CROs. This can make it challenging to ensure compliance with the latest regulations and guidelines. To address this challenge, mid-size CROs should invest in regulatory expertise and keep abreast of the latest regulations and guidelines.

Compliance 81

Compliance Branding Packaging Packaging 81

Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

Marketing 40

Marketing Compliance Packaging Packaging 40

FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or.

Packaging 52

Packaging Packaging Containment Production 52

FDA Law Blog

MARCH 28, 2022

Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied to ophthalmic products.

Regulation 40

Regulation Production Compliance Manufacturing 40

pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. About PRISYM ID.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

XTalks

MAY 9, 2023

As the demand for clinical trials continues to grow, so does the need for skilled professionals who can manage complex trial operations and ensure that studies are conducted in compliance with regulatory requirements. Ensuring compliance with applicable regulations, guidelines and ethical principles.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

Clinical Trials 78

Clinical Trials Clinical Trials Trials Packaging 78

pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

FDA Law Blog

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

Genome 102

Genome Genomics Manufacturing Production 102

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

Life Science 95

Life Science Compliance Regulation Cosmetics 95

Pharma Marketing Network

MARCH 25, 2023

This includes everything from the company’s website and social media presence to packaging and advertising. The industry is highly regulated, and companies must adhere to strict guidelines regarding the marketing and promotion of their products.

Branding 52

Branding Regulation Marketing Packaging 52

Clinical Trial Podcast

FEBRUARY 23, 2021

Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved. The PM anticipates the negative impact of compliance issues on the overall trial. A great project manager would drive to the airport and drop off that package.

Clinical Research 105

Clinical Research Research Clinical Trials Clinical Trials 105

Cloudbyz

MAY 24, 2023

Challenges in Clinical Research in Consumer Products Companies There are several inherent challenges that these companies face in conducting clinical trials: Complex Regulations: Regulatory requirements for consumer products can vary significantly by product category and geographic location, creating a challenging landscape to navigate.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

Camargo

NOVEMBER 15, 2021

The guidance aims to address country-specific versus global continuous manufacturing (CM) requirements for any new product and to harmonize global regulations. Batch steps include filter drying, milling, and packaging. Manager, Regulatory Compliance. Co-Authors: Bill Stoltman, JD. Vice President, Regulatory Operations.

Development 187

Development Manufacturing Production Packaging 187

Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

Clinical Trials 86

Clinical Trials Clinical Trials Trials Compliance 86

XTalks

JULY 5, 2022

A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Novartis trains and guides associates with a structured program consisting of ethics, risk and compliance.

Life Science 52

Life Science Compliance Packaging Packaging 52

Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

Regulation 52

Regulation Manufacturing Medicine Drugs 52

pharmaphorum

NOVEMBER 17, 2021

This year’s conference will explore the exciting advances in the combination product delivery space including insights into how the industry is adapting to the delayed EU MDR, takeaways from the global pandemic and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.

Drugs 52

Drugs Drug Delivery Engineer Production 52

Cloudbyz

JANUARY 27, 2021

Understand global regulatory implications Federal laws and regulations heavily govern clinical trials. For example, the regulations for governing trials in the US and EU allow electronic submission of clinical trial reports (with few exceptions), but this might not be the case in other countries. Package Installation.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Packaging 98

FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). This information is not included in the proposed codified language for the regulation.

Containment 52

Containment Production Protein Regulation 52

Advarra

SEPTEMBER 23, 2022

Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain. . In other words, the FDA also regulates whether investigational products may be manufactured, shipped, and administered to human subjects who participate in clinical investigations. . The IND goes into effect; and .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

Regulation 52

Regulation Compliance Manufacturing Packaging 52

XTalks

OCTOBER 12, 2022

Facilities that are engaged in manufacturing, packaging, processing, or holding foods, beverages, or dietary supplements that are consumed in the US must register with the FDA. To encourage timely submission, there is no cost associated with the renewal process.

Manufacturing 52

Manufacturing Packaging Packaging Compliance 52

Cloudbyz

MARCH 30, 2023

Regulatory compliance Regulatory compliance is critical to the success of cell and gene therapy trials, and there are many regulations to navigate. It is essential to establish clear protocols for the storage and transportation of therapies, including temperature requirements, packaging, and handling procedures.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

The Pharma Data

MAY 14, 2021

When you drink, the liver has to work to remove the alcohol from the blood instead of regulating blood sugar. I’ve set up a discounted package system of 6 bottles of GlucoFlow for you, for only 49 dollars a bottle, for a total of 294 bucks which is being offered TODAYâ?¦for CLICK NOW TO SECURE YOUR PACKAGE WHILE SUPPLIES LAST!

Production 52

Production Packaging Packaging Insulin 52

FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

Regulation 45

Regulation Production Cosmetics Sales 45

FDA Law Blog

SEPTEMBER 6, 2023

The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

Advarra

JUNE 28, 2022

There are a myriad of regulations coming into play during the drug development process. Because of this, the FDA understands sponsors may need help making sense of regulations. In order to achieve this, teams must undergo detailed planning and have a strong knowledge base of IND regulations.

Regulation 52

Regulation Drugs Manufacturing Development 52

FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

Regulation 59

Regulation Manufacturing Packaging Packaging 59

FDA Law Blog

JUNE 27, 2021

Mock internal inspections help ensure compliance and instill familiarity and confidence in employees during actual DEA inspections. Maintain controlled substances in secure areas at all times except during receiving, processing, packaging, labelling or conveying to the secure loading area. Ensure past deficiencies have been remedied.

Drugs 80

Drugs Licensing Licensing Regulation 80

FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

Production 40

Production Compliance Manufacturing Regulation 40

FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Most of the compliance dates have been passed. By Philip Won & Lisa M.

Packaging 45

Packaging Packaging Compliance Manufacturing 45

Drug Discovery World

JULY 11, 2022

As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. " Critical Considerations For Packaging And Delivery Of Gene Therapy Products." Global regulatory progress in delivering on the promise of gene therapies for unmet medical needs.

Gene Therapy 52

Gene Therapy Gene Development Production 52

pharmaphorum

NOVEMBER 24, 2022

While many production environments across all verticals must remain hygienic for product integrity, the standards that regulate pharmaceutical cleanrooms are more stringent – with unique industry-specific standards governing their use. Meeting strict standards. Enter cleanrooms-on-demand…. Solving industry challenges. About the author.

Manufacturing 96

Manufacturing Pharma Packaging Packaging Packaging 96

Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52