Drug Channels

APRIL 19, 2021

Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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FDA Law Blog

MARCH 21, 2024

Although much remains to be decided and industry is waiting for guidance from FDA related to some of these issues such as serious adverse event reporting, conference discussions all embraced the development of an appropriate internal company infrastructure to handle new requirements as part of a good faith display of compliance. By John W.M.

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Cloudbyz

APRIL 25, 2023

This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Different types of reports have specific timelines for submission, and delays may result in regulatory actions or penalties.

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FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. By John W.M.

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XTalks

DECEMBER 7, 2023

These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. A video that showcases some technological aspects of product tracing systems. Sample traceability plans. Newly added FAQs. Supply chain examples specifically for deli salads.

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Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).

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pharmaphorum

FEBRUARY 4, 2021

However, issues like compliance, governance and security often are. This is especially true for organizations with multiple locations, divisions, business units and product teams. This will help ensure consistency and compliance across the entire enterprise. . Security, Governance and Compliance are important .

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BioPharma Reporter

MARCH 3, 2022

WuXi STA says its drug product facility in Wuxi City, China has successfully passed its first pre-approval inspection (PAI) and received the GMP compliance certificate from the European Medicines Agency (EMA).

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Drug Discovery World

FEBRUARY 22, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The post Webinar: Environmental monitoring within biotherapeutic production appeared first on Drug Discovery World (DDW).

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BioTech 365

JULY 21, 2021

FDA (Food and Drug Administration) Regulatory Compliance Course for Pharma and Biotech Products (July 27-28, 2021) – ResearchAndMarkets.com FDA (Food and Drug Administration) Regulatory Compliance Course for Pharma and Biotech Products (July 27-28, 2021) – ResearchAndMarkets.com DUBLIN–(BUSINESS WIRE)–The “The FDA … (..)

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Drug Discovery World

FEBRUARY 15, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The post Webinar: Understand microbial control in biotherapy production appeared first on Drug Discovery World (DDW).

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FDA Law Blog

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. By Steven J. There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention.

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pharmaphorum

JULY 21, 2022

As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product. Doing so means that businesses can check their compliance before an FDA inspection. Implementing Pharmaceutical Quality systems. She has a Ph.D.

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FDA Law Blog

DECEMBER 2, 2021

s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. Hyman, Phelps & McNamara, P.C.’s

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BioTech 365

NOVEMBER 9, 2020

Johnson & Quin Achieves HIPAA Security Compliance Assessment Johnson & Quin Achieves HIPAA Security Compliance Assessment NILES, Ill.–(BUSINESS

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Cloudbyz

MAY 24, 2023

Consumer products companies constantly strive to develop superior products that meet the ever-evolving needs of their consumer base. The pursuit for the most effective and safe products requires rigorous clinical research, which involves meticulous trial design, recruitment, data collection, and subsequent analysis.

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Pharmaceutical Commerce

JANUARY 31, 2024

Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level.

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FDA Law Blog

JUNE 23, 2022

Karst — The American Conference Institute and Council for Responsible Nutrition are hosting the 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements live in New York next week, June 29-30. Hyman, Phelps & McNamara, P.C.’s

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Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Full actions (2017–present). 3d) 209 (FCA), at paras.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 4, 2023

Indian pharma & healthcare faces numerous challenges in the supply chain, such as lack of visibility to the recipients and the shippers, maintaining the integrity and safety of temperature-sensitive products, meeting regulatory compliance requirements, and managing logistics costs while ensuring timely delivery.

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pharmaphorum

MAY 8, 2024

This post explores how improved data compliance practices could increase production and end chronic shortages. Could data transparency finally resolve the crisis of drug shortages?

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Cloudbyz

MAY 15, 2024

The Cloudbyz eClinical platform, comprising CTMS, eTMF, EDC and Safety & Pharmacovigilance, can significantly enhance compliance with these guidelines. Continuous monitoring and real-time updates ensure that trials adhere to the established protocols and regulatory requirements, improving compliance and data integrity.

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FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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The Pharma Data

MARCH 9, 2021

Eli Lilly and Company (NYSE: LLY) today announced the upcoming retirement of two executive committee members and the naming of their successors in the company’s manufacturing operations and ethics and compliance organizations. Hernandez and Weems will report to David A. .

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The Pharma Data

NOVEMBER 23, 2020

On February 7, 2020 the NYSE American notified the Company that it accepted the Company’s plan to regain compliance before November 25, 2020 , the end of the compliance plan period. This date has now been extended to May 25, 2021. About Synthetic Biologics, Inc. Synthetic Biologics, Inc.

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Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Managing regulatory submissions through increased product and process knowledge. Products affecting regulatory pathways are typically already approved.

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Roots Analysis

APRIL 15, 2024

The production of biologics involves high degree of fragility and sensitivity involving the need for complex manufacturing capabilities, such as fermentation, aseptic fill finish , adequate storage with controlled temperatures and analytical testing to offer quality products.

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FDA Law Blog

JUNE 6, 2021

The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Attendees will gain a broad understanding of integrating device requirements into plans for development, NDA submission, and post market compliance. Hyman, Phelps & McNamara, P.C.’s

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pharmaphorum

SEPTEMBER 6, 2022

Abbie Lennox, global chief regulatory, medical, safety and compliance officer for the organisation’s consumer health division, said she hoped it will “spark a conversation” around the need to promote science-led self-care. “We Consumers need products they know they can trust.”. The five principles.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Pharmaceutical companies hold permission to market their products directly to consumers. Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers.

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Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. In more serious instances, sponsors might see their products recalled entirely.

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Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Wholesalers can be either full-line wholesalers, who purchase the complete product line of a company, or specialised companies, which purchase speciality drugs to sell to clinics and hospitals. GDP and GMP advisory.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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Pharmaceutical Commerce

MARCH 30, 2023

As a November deadline looms for industry compliance with an interoperable system for product tracing, there is more urgency in the US pharma supply chain.

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Advarra

OCTOBER 26, 2023

Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. Requirements for Transport of Investigational Products Accidents can happen. Some institutions require additional specific paperwork, so be sure to review internal policies prior to transport of the investigational products.

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FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Hyman, Phelps & McNamara, P.C.

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