Express Pharma

DECEMBER 13, 2023

In this exclusive interview, Sudhir Kandarth, General Manager – APAC Commercial at Veeva Systems draws from 16 years of experience in the enterprise software and pharma industry to share a wealth of insights about transformations in the life science business landscape.

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Express Pharma

SEPTEMBER 26, 2023

In this video: Girraj Tripathi, Senior General Manager and Site Quality Head, Sun Pharma Topic: Regulatory challenges and compliance Key Takeaway: The cost of poor quality and regulatory non-compliance is huge. They cause loss of time, money and reputation.

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Express Pharma

MAY 6, 2024

They examined packaging compliance, promoting sustainability and scaling up production with efficient project management and eco-friendly solutions. The first day’s sessions also explored new models for pharmaceutical manufacturing and quality packaging, as well as pressing supply chain and logistics issues.

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Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 94

Orsini Pharmacy

APRIL 18, 2024

Edenbridge accepted Orsini into YARGESA's limited distribution network because of Orsini's deep experience with rare diseases, home nursing network and ability to provide comprehensive compliance programs to support patients and providers in obtaining coverage and managing therapies.

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Specialty Pharmacies 93

Express Pharma

JUNE 7, 2023

The Standard Quality and Regulatory Documentation (StaQRD) electronic data standard includes quality and regulatory compliance data. Building on this CoA standard, StaQRD includes nine additional types of compliance documentation in the initial launch, such as nitrosamine risk assessment, allergen statements and GMP compliance documents.

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Documentation 81

PharmaTech

NOVEMBER 8, 2022

Session 1: Wednesday, November 9, 2022 at 8am EST |1pm GMT | 2pm CET Session 2: Wednesday, November 9, 2022 at 2pm EST |1pm CST | 11am PST Join Merck, IPS, and Synergis Software on November 9th to learn how Merck is leveraging the Synergis Adept engineering document management platform to address these issues while driving standards and best practices. (..)

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Documentation 52

European Pharmaceutical Review

MAY 17, 2023

A market report has shown that to improve efficiency, quality and to reduce costs in drug manufacturing , Pharma has been adopting automated quality management systems, digitalisation of processes and integration of data analytics. What is limiting growth of the pharmaceutical quality management systems market? billion by 2031.

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Pharmaceutical Companies Pharmaceutical Companies Biosimilars Drug Development 80

Express Pharma

SEPTEMBER 20, 2023

In this video: Rohit Chakravorty, Application Manager- Life Sciences: APAC, Veolia WTS Analytical Instruments Topic: Empowering pharma compliance: Exploring cutting-edge solutions Key Takeaway: At Sievers, we believe compliance is the key, and thus we comply with all the four critical water parameters: Conductivity, TOC, Endotoxin and Bioburden The (..)

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FDA Law Blog: Biosimilars

MAY 16, 2024

But there has been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA regulations allowed employees to divert staggering quantities of controlled substances.

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Controlled Substances Hospitals Intravenous Solutions 59

FDA Law Blog: Biosimilars

NOVEMBER 30, 2023

The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.

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Communication 59

European Pharmaceutical Review

JULY 4, 2023

However, critical disciplines within the field responsible for ensuring safe and effective drug products, including quality assurance and compliance, remain mysterious or invisible to many. Quality assurance and compliance-related plans are affected by supply chain issues.

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Drug Development Communication Dosage Chemotherapy 80

Express Pharma

APRIL 24, 2024

Nilesh Gupta, Managing Director, Lupin said, “We are pleased to receive the EIR with VAI status from the USFDA as an outcome of the recent inspection of our Aurangabad facility. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

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FDA Law Blog: Biosimilars

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Ellison, Managing Partner at HPM. Wicks was instrumental in the firm’s approach to client-centric solutions and innovative compliance strategies. Hyman, Phelps & McNamara, P.C. During her previous stint with HPM, Ms.

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Drug Development 52

Express Pharma

MARCH 12, 2024

They aim to facilitate upgradation of quality standards, compliance with revised Schedule M and obtaining World Health Organisation’s (WHO) Good Manufacturing Practice (GMP) certifications. The scheme aims to encourage widespread adoption, providing comprehensive support for compliance with new standards.

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Documentation Pharmaceutical Manufacturing 101

PharmaTech

FEBRUARY 2, 2023

Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

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Method Validation 97

Express Pharma

MAY 30, 2023

ValGenesis and Life Science Consulting have partnered to provide digital validation solutions to enhance compliance and quality across life sciences disciplines such as production, quality control and assurance, information technology, and research and development (R&D). journey.

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Express Pharma

MAY 2, 2024

1,000 crores in primary and secondary funding from a fund managed by Morgan Stanley Private Equity Asia and India Life Sciences Fund – IV (ILSF – IV), which have jointly acquired a controlling stake from existing investors and infused primary capital in the company. Maiva Pharma has raised Rs.

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Dosage 84

European Pharmaceutical Review

OCTOBER 25, 2023

The CDMO’s Case Management Services provides end-to-end professional supply chain management and orchestration for autologous and allogeneic cell and gene therapies. It also seamlessly manages and retrieves study-related data, eliminating paper-based records and improving compliance with regulatory guidelines.

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Packaging 90

Pharmaceutical Commerce

JUNE 27, 2023

explains the importance of visibility for risk management and compliance issues when navigating the supply chain and highlights solutions to support life sciences. Amy Shortman, Overhaul Co.,

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Express Pharma

SEPTEMBER 26, 2023

In this video: Neeraj Shukla, General Manager Sales (North India), Optel India Topic: Traceability 2.0: Optimize for performance, sustainability and compliance Key Takeaway: The traceability journey begins with smart digital transmission.

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Express Pharma

DECEMBER 7, 2023

A key learning from his session was that as the life sciences sector evolves and market demands change, traditional approaches to enable compliance must make way for newer and more effective models. He explained about the role of performance management, leadership, people, culture, risk and quality management etc.

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Generic Medicine Documentation 102

PharmExec

DECEMBER 20, 2023

Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert who discusses maximizing returns on investment, upholding data integrity while managing cost containment, and adopting digital best practices.

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PharmExec

DECEMBER 20, 2023

Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert who discusses maximizing returns on investment, upholding data integrity while managing cost containment, and adopting digital best practices.

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Express Pharma

JANUARY 9, 2024

Supriya Lifescience’s Lote Factory underwent a rigorous inspection by ANVISA, and received “Zero” observations in compliance. highest quality standards and employing advanced production and manufacturing techniques.

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Pharmaceutical Companies Pharmaceutical Companies 93

pharmaphorum

FEBRUARY 4, 2021

Salesforce org management is usually not the headliner for CIOs and CTOs looking to catch up on executive-level trends and issues pertaining to technology. However, issues like compliance, governance and security often are. The result; costly problems that could have been avoided with proper Salesforce org management. .

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Documentation 105

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. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

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Drug Channels

SEPTEMBER 18, 2023

Showcasing high level discussions on access strategy, patient interactions, case management, compliance practices and more, this two-and-a-half-day event helps navigate complex compliance hurdles to advance and enhance your patient-oriented programs. And so many more! Comprehensive Content and Dynamic Features Include : 2.5

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Express Pharma

APRIL 17, 2024

Merck recently announced the appointment of Dhananjay Singh as the Managing Director of Merck Life Science in India, in addition to his current position as Head of Science & Lab Solutions Commercial, India. said Pratima Reddy, Country Speaker, Merck India. said Pratima Reddy, Country Speaker, Merck India.

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Express Pharma

JUNE 27, 2023

Our experienced personnel handles every aspect of your move: – Relocation planning and documentation – Layout consultation for your new site – Deinstallation, reinstallation, and performance verification – Instrument requalification and compliance testing – Inventory management – Post-move documentation We move it all.

Documentation 97

Documentation 97

Pharma and Life Sciences Blog

FEBRUARY 23, 2024

Unleash the Hidden Power of Effective Catalog Management annmarie@AZglo… Fri, 02/23/2024 - 22:40 An often overlooked yet powerful tool to streamline procurement processes and enhance cost optimization is robust catalog management. This guides users toward compliant choices and minimizes inefficient spending.

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PharmExec

FEBRUARY 7, 2023

The Caremark and Park doctrines require directors and managers of life sciences companies to address regulatory compliance proactively and vigorously.

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Express Pharma

MARCH 20, 2024

Panelists in this video: + Avinash Kumar Talwar, VP – MRO & Pkg.

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Packaging Labelling 52

European Pharmaceutical Review

MARCH 5, 2024

” According to BeiGene, since joining BeiGene in 2022 as the Global Head of Operational Excellence, De la Rocha has “championed impactful changes in clinical development, driving compliance, productivity, and efficiency.” .”

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Medical Schools 91

pharmaphorum

JULY 28, 2022

While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. About the Author.

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Diabetes Dosage Pharmaceutical Manufacturing Documentation 102

Pharmacy Times

SEPTEMBER 18, 2023

Strategies include improving compliance, convenience, symptom management, and reducing stigma around pre-exposure prophylaxis for HIV.

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FDA Law Blog: Biosimilars

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

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PharmaTech

MARCH 14, 2023

An Overview with Aubrey Hogan Verista’s Head of Regulatory Compliance and Product Lifecycle Management

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