European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. Complex manufacturing processes and development of appropriately qualified or validated test methods present unique challenges which teams must overcome.

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Drug Development Communication Dosage Chemotherapy 80

European Pharmaceutical Review

JULY 4, 2023

The document contains requirements and guidance for testing for bacterial endotoxins. It can therefore support development of safe and effective products and medicines, while ensuring regulatory compliance. This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.

Documentation 93

Documentation Labelling 93

FDA Law Blog: Biosimilars

JANUARY 8, 2024

In a “hot” deal market, its worthwhile reiterating the fundamentals of regulatory due diligence that don’t change, no matter how attractive the deal or how short the window is to seize the opportunity. Having the right diligence team is critical because proper risk assessment of regulatory risk requires a broad range of expertise.

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Pharma Marketing Network

JULY 26, 2023

While maintaining a vigilant approach to marketing compliance is crucial, the FDA may be strategically choosing to address more immediate public health concerns, leading to fewer marketing violation letters being issued.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 97

pharmaphorum

OCTOBER 27, 2022

Why is guidance needed? Uses of social media is continually expanding and it has been difficult for companies to apply general advertising rules and guidance to the modern world. What is the scope of the Guidance? It identifies the most used social media and digital channels and sets out specific guidance for each.

Communication 93

Communication Pharmaceutical Manufacturing Packaging Documentation 93

PharmaState Academy

FEBRUARY 29, 2024

CASE STUDY The Regulatory Riddle Unraveling Sales Strategies in the Pharmaceutical Jungle Table of Contents Case Study Scenario: In the heart of XYZ Pharma’s bustling headquarters, the sales team gathers for a crucial meeting that could shape the future of the company. Option 01 Maximizing profits at any cost.

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European Pharmaceutical Review

DECEMBER 19, 2023

The workplan, which runs until 2028, will help the European medicines regulatory network (EMRN) embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data and supporting more robust decision-making to benefit public and animal health.

Packaging 90

Packaging Documentation 90

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 92

Documentation Pharmaceutical Manufacturing 92

European Pharmaceutical Review

JULY 10, 2023

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes.

Dosage 82

Dosage 82

FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms.

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Labelling 59

Big Molecule Watch

JULY 18, 2023

On June 30, 2023, the Centers for Medicare & Medicaid Services (CMS) released its updated final program guidance covering the Inflation Reduction Act’s Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026.

Drug Pricing 52

Drug Pricing 52

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

Documentation 91

Documentation Pharmaceutical Manufacturing Packaging Labelling 91

pharmaphorum

JULY 1, 2022

Navigating The MDR and IVDR and Best Strategies for Compliance. In addition, the conference will consider the evolving regulatory landscape for digital health software. Gain insights from pharma regulatory experts in compliance and companion diagnostics. SAE Media Group’s Inaugural Conference…. 14 – 15 November 2022.

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European Pharmaceutical Review

APRIL 2, 2024

Pharmacopoeia guidance on recombinant BET methods Currently, the regulatory landscape surrounding the use of (rFC) and (rCR) can be complex and confusing. It is important to understand the guidance provided by different pharmacopoeias. Additionally, there are positive regulatory developments on the horizon.

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Method Validation Medical Schools 87

Syner-G

SEPTEMBER 18, 2023

As a small company, Yumanity did not have the experienced professionals needed to manage each stage of the manufacturing, quality, and regulatory processes (collectively called CMC – Chemistry, Manufacturing and Controls). Syner-G was flexible and provided the guidance and expertise Yumanity needed to ramp up and ramp down as needed.

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Drug Development 45

FDA Law Blog: Biosimilars

APRIL 8, 2024

Those numbers are the stars in the manufacturing universe that CDER uses to plot its regulatory course, so it’s of interest to see how they have remained consistent even if OPQ didn’t take the next step of connecting the points in those constellations. The role of technology on quality was another feature.

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Immunity Immunization 59

Syner-G

SEPTEMBER 15, 2023

Adhering to CLD best practices is time-consuming, labor-intensive, and costly, but streamlining strategies for accelerating timelines include screening technologies and purpose-fit cell lines to balance speed, quality, and compliance while optimizing cell culture conditions.

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Drug Development Documentation Process Improvement Compounding 59

pharmaphorum

SEPTEMBER 29, 2022

If so, developers must develop and execute on a regulatory strategy. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. More information about this process may be found in FDA’s 513(g) Guidance Document.

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Documentation 96

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. Key changes to GAMP 5. The GAMP 5 Second Edition includes: Six completely new appendices.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 84

Express Pharma

OCTOBER 3, 2023

He also spoke on industry’s challenges and offered guidance on how to navigate successfully in an evolving regulatory environment. The new version of Schedule-M is designed to ensure compliance to standards of drugs, promote exports, promote innovation and also to build trust and confidence on quality of drugs manufactured and sold.

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Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

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Documentation Compounding Pharmaceutical Manufacturing 52

pharmaphorum

DECEMBER 13, 2022

Over the past few years, many clinical study administrators wanted to use the bring your own device (BYOD) model within their eCOA, but they were typically constrained by regulatory requirements or misunderstandings around the approach. Potential regulatory compliance: Regulators recently began recognizing the power of utilizing BYOD devices.

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Data Entry HIPAA Communication 59

pharmaphorum

JUNE 8, 2022

Conference Chairman: James Drinkwater, Head of Aseptic Processing Special Interest Group PHSS and Head of GMP Compliance, F Ziel GMBH. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

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pharmaphorum

NOVEMBER 17, 2021

Hear key regulatory updates from regulatory bodies including FDA and WHO on guidance for regulatory compliance. FEATURED REGULATORY SPEAKERS: Caroline Strasinger, Master Reviewer, Office of Pharmaceuticals Quality, CDER/FDA. We look forward to welcoming you to the conference in January. pharmaphorum .

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Vaccines 52

Pharma in Brief

JANUARY 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. On the regulatory front, seemingly all of Canada’s agencies – the PMPRB, pCPA, CADTH, Health Canada – had important developments in 2023, including that CADTH is being expanded into a new agency: the CDA.

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Drug Pricing Documentation Biosimilars Vaccines 52

European Pharmaceutical Review

DECEMBER 13, 2022

The 1938 law effectively changed the focus of the Food and Drug Administration (FDA) from a policing agency to a regulatory agency tasked with overseeing the safety evaluation of new drug products. Pharmacopoeia guidance on DEG and EG. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007.

Compounding 92

Compounding Packaging 92

GMPSOP

DECEMBER 24, 2023

Compliance with GLP requirements is essential for pharmaceutical product research, development, and testing laboratories. GLP compliance also helps maintain laboratory personnel’s safety and the environment. Four key aspects of QC compliance are listed below. Access to exclusive content for an affordable fee.

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Documentation Method Validation Packaging Data Entry 52

European Pharmaceutical Review

JULY 21, 2023

Recent guidance published by the European Medicines Agency outlines measures that will be taken to increase preparedness for the autumn/winter 2023-2024. The shortages stem from increased demand, part discontinuation, compliance requirements, and a scarcity of semiconductor chips.

Vaccines 94

Vaccines Pharmaceutical Manufacturing Communication Hospitals 94

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

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Labelling 45

Quality Matters

AUGUST 7, 2023

Pharmaceutical community eyeing FDA guidance on nitrosamines with great interest Nitrosamines are naturally occurring chemical compounds that people are regularly exposed to at low levels. We will all surely learn more in the coming days as our scientists and regulatory colleagues sink their teeth further into the new update.

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Compounding 52

Syner-G

SEPTEMBER 28, 2023

Lastly, inadequate regulatory documentation can be avoided by meticulously compiling comprehensive, guideline-compliant, regulatory documentation. A team of consultants with regulatory, clinical, nonclinical, and CMC expertise was assembled to provide strategic input and guidance on the US development program.

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Documentation Drug Development Packaging 59

pharmaphorum

JUNE 11, 2021

Governments and regulatory bodies endeavour to improve cybersecurity by establishing stringent compliance requirements. However, it is vital to understand that compliance is not security. HIPAA in the United States, a regulatory reference, was designed to protect patient privacy but not necessarily data security.

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Vaccines HIPAA Immunity Immunization 111

National Association of Boards of Pharmacy

APRIL 3, 2024

Whether you are opening a new facility, seeking an accreditation, or operating business as usual, at some point, you will encounter a third-party organization or regulatory agency. Regulatory agencies and accreditation organizations expect a company to adhere to its P&Ps. Was the task specified within the procedures?

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Documentation 45

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. Improving access to individuals with rare diseases in remote settings. About the interviewees. appeared first on.

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Packaging Generic Medicine Communication Hospitals 80

Quality Matters

JUNE 6, 2023

The complexities of the excipient supply chain, however, can present unique risks related to quality, regulatory oversight, and overall supply chain resiliency. In addition, as novel excipients and uses emerge, the relationship between quality, testing, performance, and compliance can become more complicated.

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Dosage Packaging Documentation Drug Development 52

European Pharmaceutical Review

JUNE 23, 2023

This approach conserves product for patients, maintains compliance and delivering assay and process information on the microbiological status of gene therapy products. Challenges in bioburden testing Gene therapy manufacturing processes result in low yields, particularly in early product development stages.

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Documentation 72

European Pharmaceutical Review

SEPTEMBER 26, 2023

Depending on the size and complexity of the dataset, pharma companies have the option of several migration methods from which to select the one most suitable for their needs and that maintains regulatory compliance. Choosing the best approach to maintain data integrity requires careful consideration.

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Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 93