Rethinking Clinical Trials

JULY 28, 2022

The NIH Pragmatic Trials Collaboratory really has been a fertile ground across NIH,” said Boineau, who is the director of the Office of Clinical and Regulatory Affairs at the National Center for Complementary and Integrative Health (NCCIH). “It

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The Pharma Data

MAY 4, 2021

During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. The two sides discussed the proposal and industry “agreed to discuss regulatory science internally and revisit in a future meeting.”. .

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Clinical Trial Podcast

FEBRUARY 23, 2021

Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs. Go-to person for clinical trial budget, timelines, resources. Developing and actively managing clinical trial finances, timelines, and resource allocation is necessary for a smooth trial execution. That’s when this post comes handy.

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The Pharma Data

MAY 12, 2021

RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates , Regulatory Focus 11 November 2020). . FDA’s efforts to build capacity to meet increased demands include modernization of its time reporting approach and developing resource capacity planning adjustment (CPA) capabilities. Source link.

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XTalks

FEBRUARY 5, 2021

The company’s proven expertise and established infrastructure in areas including clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain as well as providing support in several countries around the world makes it well-positioned to assist in global vaccine efforts against COVID-19.

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The Pharma Data

JANUARY 27, 2021

“Today’s actions are necessary to protect the safe supply of alcohol-based hand sanitizers,” Judy McMeekin, FDA associate commissioner for regulatory affairs, said in an agency news release. More News Resources. consumers in mind.” ” More Information. © 2021 HealthDay. . consumers in mind.”

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pharmaphorum

DECEMBER 9, 2021

She rotated through regulatory affairs, external innovation, and self-care R&D. A true advocate for diversity and inclusion, she also sits on the EMEA Leadership Team for Johnson & Johnson’s LGBT+ employee resource group. Heather’s passion for integrated wellness goes beyond her day-to-day responsibilities.

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XTalks

NOVEMBER 7, 2023

They are key in clarifying the optimal use of products, fostering scientific and medical dialogue among their colleagues and peers and serving as a vital resource for the medical community at large. As part of the medical affairs division, they may be assigned to a specific geographical region, which can require considerable travel.

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XTalks

OCTOBER 18, 2022

The reason why pharmaceutical, biotech, and medical device sponsors are spending resources on clinical-related services is that CROs are extremely experienced in conducting clinical trials. Regulatory affairs and medical writing. Source: [link]. 3) A Great Workplace. Clinical trial management. Biometrics and data sciences.

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XTalks

JANUARY 20, 2022

In this role, a consultant may design a laboratory research project and plan the resources needed to make it happen. Regulatory compliance: This involves assisting a client to meet regulatory requirements. Product development: In this area, a consultant helps a client launch a new product.

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XTalks

OCTOBER 4, 2023

She has worked both in country-level and global roles, working on all components of core market access areas: health economics, access strategy, pricing, government affairs and patient advocacy. Dr. Heather McDonald: You almost can’t start early enough when looking at how to optimize patient access for innovative medicines.

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Cloudbyz

JUNE 11, 2023

Here, the study’s operations, instead of being consolidated at a particular site, are distributed and carried out across various remote locations, leveraging digital tools and resources. Throughout each stage of a DCT, patient safety, data security, and regulatory compliance are of utmost importance.

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XTalks

JUNE 5, 2023

Pharmaceutical portfolio planning involves crucial decision-making about which drug development projects to pursue and how to allocate resources effectively. This could be based on new scientific research, unmet medical needs or changes in the regulatory or market environment.

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The Pharma Data

JUNE 2, 2022

Today’s Supplement Your Knowledge resources will provide reliable information about the potential benefits and risks associated with dietary supplements, such as vitamins, minerals, and herbs, they may consume. More than half of all Americans take dietary supplements daily or on occasion.

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Advarra

JUNE 21, 2022

The stage and complexity of developmental programs help define the appropriate time to investigate a PV resourcing model. This is challenging for emerging biopharma organizations because PV resources are highly specialized, rare, and expensive. Q: What role does a drug safety program play in a PV organization?

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XTalks

JUNE 14, 2023

Pharmaceutical portfolio planning involves crucial decision-making about which drug development projects to pursue and how to allocate resources effectively. This could be based on new scientific research, unmet medical needs or changes in the regulatory or market environment.

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Cloudbyz

APRIL 19, 2021

It registered a revenue of ~US$430cr in 2019 and is operational with a massive resource strength of 14,000 employees. Cloudbyz analyzed that our client was using conventional systems that constrained its capacity in the assessment and reporting of adverse events and regulatory adherence. and submission to regulatory affairs.

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pharmaphorum

JANUARY 25, 2021

It has been thrilling to watch how COVID-19 has catapulted the pace of collaboration among regulatory agencies. To date, we have seen significant cross-industry collaborations to develop standards and new regulatory guidance for acceptable RWE use cases. public education. clinical trial diversity. real-world evidence (RWE).

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pharmaphorum

JANUARY 27, 2023

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. The most important thing is that you have a framework to be able to identify them, pick them up quickly and around that regulatory framework. We know that there are 3.5

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Drug Discovery World

FEBRUARY 22, 2023

You’ll also need to develop brand materials, get your supply chain in place, ensure medical affairs are ready to go, build reimbursement dossiers and have pricing strategy set. It’s a busy time so it’s understandable that many companies struggle balancing resources, timescales and budgets. before 18 months.

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pharmaphorum

MAY 18, 2021

Pre-commercial & Emerging pharma companies may not think they have the resources to match the launch strategies of big pharma. Smaller companies tend to think that they are missing the resources to use similar launch strategies as big pharma, but with the right efficiencies, they can make considerable savings on marketing budgets.”.

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The Pharma Data

DECEMBER 3, 2020

Rentschler Biopharma – Germany-based Rentschler announced Diana Wiedmann will lead the global human resources team as senior vice president. Most recently Wheadon served as head of Global Regulatory Affairs, Patient Safety and Quality Assurance at AstraZeneca Pharmaceuticals.

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The Pharma Data

OCTOBER 15, 2020

Once established, Dr Tedros said that he would be calling on partners to mobilize additional resources beyond WHO’s budget to scale up support to countries for their response to NCDs. Dr Tedros described WHO’s commitment to work with Task Force members to establish the NCD and Mental Health Multi-Partner Trust Fund. Dr Tedros. . .

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XTalks

DECEMBER 22, 2022

NORD has many programs that aim to do that, including programs administered by our departments of Patient Services, Membership, Research and Medical Affairs. Since only about 5 percent of rare diseases have FDA-approved treatments, it is vital that we increase the pace of rare disease clinical research.

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XTalks

MAY 6, 2021

Drug regulatory affairs. Rather than reducing investments, many companies in these industries poured more resources into R&D, which led to the development of vaccines, as well as new distribution and tracking innovations. Quality control. Intellectual rights. Technology transfers. Research and development (R&D).

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Intouch Solutions

APRIL 24, 2024

As medical affairs within pharmaceutical companies continues to adopt omnichannel solutions, it must meet a growing volume of content demands. Modular content strategy presents a disciplined and structured solution for creating medical assets by utilizing preapproved content blocks, or “modules.”

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Drug Discovery World

AUGUST 10, 2023

In this article, Amplexor asks some of the company’s closest industry partners and BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and explore some of the most prominent themes and priorities seen throughout 2023.

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Drug Discovery World

JANUARY 23, 2023

Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. Warner has a wealth of experience in EU and US regulatory affairs, and a special interest in orphan drugs. The post Regulatory affairs in 2023: key trends and changes appeared first on Drug Discovery World (DDW).

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pharmaphorum

NOVEMBER 30, 2022

The Veeva Systems Summit is about sales, medical, and marketing – the commercial side of things, but on the development side Veeva also works in clinical data, clinical operations, regulatory, quality, and safety – and it is starting to connect the functional areas. Excellence, coordination, and connection.

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FDA Law Blog

DECEMBER 11, 2023

Regulatory affairs professionals with significant expertise in diagnostics are already in short supply. Thus, it is unclear how FDA will have resources to field pre-submissions and the anticipated premarket submissions. This would require a massive increase in staffing and training. [8] of 510(k) decisions, respectively. [13]

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XTalks

FEBRUARY 2, 2023

The proposed changes will include building a more robust regulatory program, protecting the US food supply and promoting better nutrition. The new strategy will address findings from these internal and external evaluations, which identified broader issues surrounding culture, structure, resources and authorities.

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XTalks

FEBRUARY 10, 2023

The rapidly expanding landscape of cell therapy trials has put an operational strain on many clinical sites due to limited resources and infrastructure. “In In addition, Dr. Jan Ohotski, Principal Regulatory Submissions Technical Advisor, Medpace, offered insights on strategies to overcome regulatory hurdles in cell therapy trials.

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The Pharma Data

JANUARY 31, 2021

We will continue to work closely with our collaborators and regulatory authorities worldwide to help make our vaccine accessible to those most in need as quickly as possible.” Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

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Delveinsight

SEPTEMBER 8, 2021

A group of experts specialized in the field of pharmacology deals with clinical/non-clinical testing, biologic design and manufacturing, regulatory agency interactions, submission preparation, and so on. Regulatory Affairs. Pharma Consultants rectify any issues that arise during the registration process.

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Drug Discovery World

JULY 27, 2023

Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA).

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The Pharma Data

DECEMBER 23, 2020

Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA). View original content: [link]. .

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The Pharma Data

MAY 7, 2021

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. Data related to a therapy or vaccine “must be published at the time of finalization of the regulatory review,” they said, regardless of whether the decision is positive or negative. “It

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