European Pharmaceutical Review

FEBRUARY 29, 2024

According to the Janssen Pharmaceutical Companies of Johnson & Johnson and NICE, DVCd is recommended for the rare bone marrow disorder, only if daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies 105

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

According to internal documents obtained by the Observer , Novo Nordisk wanted “data from the Department for Work and Pensions” to “ help profile those who are most likely to return to the labour market”. These individuals could then be targeted with Wegovy, the brand name for the company’s weight-loss drug semaglutide.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Drug Patent Watch

DECEMBER 10, 2024

Quality Documentation and Manufacturing Expertise CDMOs are experienced in generating high-quality documentation required for regulatory submissions and have extensive expertise in drug development and manufacturing.

Documentation 93

Documentation Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies 93

Pharma Pathway

DECEMBER 1, 2022

Officer-Executive-Production (API) -B.Sc (Chemistry) with 2 to 5 years of relevant experience in API Production of pharmaceutical Company. Should have exposure to regulatory requirement of documentation. Should have exposure in handling reactors, centrifuges and clean room equipment with sound knowledge in cGMP and SOPs.

Documentation 72

Documentation Pharmaceutical Companies Pharmaceutical Companies 72

European Pharmaceutical Review

JULY 18, 2023

Some pharmaceutical companies are increasing their R&D spending to increase product numbers. With major pharmaceutical companies implementing these approaches, this is a major contributing factor to rapid growth of this sector. Also noted in the report was the shift towards cloud-based systems.

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 98

pharmaphorum

JANUARY 18, 2021

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

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Documentation Immunization Immunity Pharmaceutical Companies 94

pharmaphorum

AUGUST 17, 2021

Sponsors and developers of AIs – including pharmaceutical companies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies 116

STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports.  A Or you may want to take stock of your life. But be safe. Enjoy, and see you soon.

Diabetes 177

Diabetes Biosimilars Documentation Compounding 177

Pharma Pathway

FEBRUARY 22, 2023

Apply Now Job Description Bharat Parenterals Limited is a Gujarat based pharmaceutical Company , established in 1992 by Mr. Ramesh Desai, who started the Company with a vision of making world class affordable medicines in Gujarat. Review of the dossiers, DMF & Technical documents.

Documentation 73

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 73

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.

Omnicell 98

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Pharma Pathway

SEPTEMBER 15, 2022

a Specialty Pharmaceutical Company engaged in Development, Manufacturing and Marketing of quality finished dosages in domestic and International markets is looking for suitable candidates for its formulation facility at Dahej, Bharuch, Gujarat. Ajanta Pharma Ltd.-Walk-In Job Description. Ajanta Pharma Ltd. , Maintain social Distancing.

Dosage 90

Dosage Documentation Pharmaceutical Companies Pharmaceutical Companies 90

Pharmafile

MAY 9, 2024

UK-based pharmaceutical company AstraZeneca has announced that is it voluntarily withdrawing its COVID-19 vaccine Vaxzevria due to a drop in global demand. The withdrawal also comes after AstraZeneca admitted in court documents that the vaccine can cause thrombosis with thrombocytopenia syndrome (TTS).

Vaccines 59

Vaccines Documentation Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. Remaining compliant is imperative to the life sciences industry, so adhering to regulatory requirements is mandatory.

Documentation 104

Documentation Pharmaceutical Companies Pharmaceutical Companies 104

Pharma Pathway

SEPTEMBER 22, 2022

is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Reddy’s Laboratories Ltd.-Walk-In Job Description. Dr. Reddy’s Laboratories Ltd.

Biosimilars 79

Biosimilars Documentation Pharmaceutical Companies Pharmaceutical Companies 79

Syner-G

SEPTEMBER 20, 2023

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. pharmaceutical company achieve on time for Phase III clinical trials appeared first on SYNER-G.

Process Improvement 40

Process Improvement Pharmaceutical Companies Pharmaceutical Companies Documentation 40

European Pharmaceutical Review

JULY 5, 2023

According the PDA, the standardised quality criteria in TR 43 are intended as a guidance overview for container manufacturers and for incoming container acceptance inspection at pharmaceutical companies.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 96

Pharma Pathway

JANUARY 23, 2023

Exemed Pharmaceuticals-Walk-In Interview for QA/ Formulation/ Engineering On 25th Jan’ 2023 Job Description Walk-In Interview for QA/ Formulation/ Engineering On 25th Jan’ 2023 @ Exemed Pharmaceuticals Company Name: Exemed Pharmaceuticals •Department: QA Position: Asst.

Documentation 80

Documentation Pharmaceutical Companies Pharmaceutical Companies 80

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

pharmaphorum

MARCH 26, 2021

Comms company Envision Pharma Group has acquired doDOC Corp, a document collaborative review, editing and authoring firm. doDOC enables simultaneous collaboration in the review, editing, and authoring of documents among multiple users.

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies 59

pharmaphorum

OCTOBER 20, 2020

The pandemic has triggered a change in how pharmaceutical companies are engaging with healthcare professionals. When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceutical company engagement during the crisis. The answer was yes.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. There may be a bit of a frenzy over the next few months as teams adapt to new concepts, language, new documents, SOPs, and clause numbers.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Pharma Pathway

FEBRUARY 14, 2023

Should have exposure to regulatory requirement of documentation. Executive The incumbent should be B.Sc/ M.Sc (Chemistry) with 3 to 6 years of relevant experience (Pharmaceutical Only) in analyse the Raw Materials, In -Process and intermediates finished product and Stability samples. Quality Control (API): Executive/ Sr.

Documentation 57

Documentation Pharmaceutical Companies Pharmaceutical Companies 57

Pharma Pathway

NOVEMBER 28, 2022

Emcure Pharmaceuticals- Openings for ITI Fitter/ Electrical Technician/ Electrical Engineer/ Instrument Engineer-Apply Now. Emcure Pharmaceuticals, We are a fast-growing Indian Pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of biopharmaceutical products globally. Job Description.

Documentation 76

Documentation Pharmaceutical Companies Pharmaceutical Companies 76

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 30, 2022

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them. Submission status quo.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. Sequella is a US-based pharmaceutical company that develops antibiotics to address drug resistant infections. Sequella is developing SQ-109 for the treatment of pulmonary tuberculosis.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

Viseven

JULY 10, 2024

As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Express Pharma

DECEMBER 30, 2024

Jayakumar also spoke about the detailed procedures and SOPs needed for investigating market complaints and how these systems should be integrated into a companys overall quality management system.

Documentation 59

Documentation Communication Packaging Pharmaceutical Companies 59

GMPSOP

MARCH 25, 2024

Additional documents included each month. Category 1 Standard hardware components Standard hardware components should be documented, including manufacturer or supplier details and version numbers. Any hardware configuration should be defined in the design documentation and verified in the installation qualification stage.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

pharmaphorum

NOVEMBER 17, 2020

Pharmaceutical companies often struggle to actively involve patients in the design phase of clinical trials but doing so can have huge benefits for the sustainability and success of research. In 2014 Keith was fortunate to become a full-time salaried patient research ambassador at Liverpool Heart and Chest Hospital Trust.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 116

European Pharmaceutical Review

SEPTEMBER 26, 2023

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

Documentation 105

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 105

Pharma Pathway

DECEMBER 30, 2022

Alembic Pharmaceuticals Ltd- Openings for Trainee- IT Helpdesk – Apply Now. Alembic Pharmaceuticals Ltd. is an Indian multinational Pharmaceutical company headquartered in Vadodara city of Gujarat-India. Alembic pharmaceuticals Ltd. Updating and maintaining customer records and documentation.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

GMPSOP

OCTOBER 26, 2022

Table of Contents What is the concept of validation in pharmaceutical industry? ” Validation is a critical concept in the pharmaceutical industry. .” ” Validation is a critical concept in the pharmaceutical industry. Additional documents included each month. All written and updated by GMP experts.

Documentation 52

Documentation Method Validation Packaging Pharmaceutical Companies 52

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents.

Compounding 96

Compounding Drug Development Documentation Pharmaceutical Companies 96

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59