BioPractice

BioPractice Our Objective is to leverage Knowledge & Expertise of highly skilled professionals in the field of B

Our Objective is to leverage Knowledge and Expertise of highly skilled professionals in the field of Biotechnology,BioMedical,Bioengineering and BioInformatics to contribute towards adopting the BestPractices,Ethices and Content in these Fields. We strive towards Creating a world where the top notch professionals,researchers and practitioners share and spread the knowledge with the insight to help startups grow into a Successful enterprise in a qualitative way.

05/14/2020

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Friday, 22nd May, 2020 01:00 PM EST 10:00 AM PST

As regulations change and become more stringent, one aspect of compliance has not changed, and that is ensuring changes, deviations, validations and risk assessments are done properly and have a proper justification and rationale. It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.

In this webcast, you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate to the reader why the process was performed the way it was.

Areas Covered in the Session:

How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
Determine alternatives or options to the proposed solution
Analyze costs, benefits, impacts, and risks of the proposed solution
Validate the solution, assess product impact to the market
Determine impact to the patient, system or firm as a result of your findings

02/04/2020

E6 R2 ICH GCP GUIDELINES LATEST VERSION

02/03/2020

Latest Guidelines on ICH GCP R2
on 28th of February 2020 @ 5:00 PM EST .

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects. Compliance with this standard provides public assurance that the rights, safety, and
well-being of trial subjects are protected, consistent with the principles that have their origin
in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP guidance is to provide a unified standard for the European Union,
Japan, and the United States to facilitate the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions

12/17/2019

Evaluating Biomarkers During Clinical Trials for Immunotherapies

How biomarker evaluation allows a comprehensive profiling of the tumor and is mandatory to elucidate actionable or resistance mechanisms to treatment in solid cancers. Next, Professor Fabrice Barlesi, Head of Multidisciplinary Oncology and Therapeutic Innovations at APHM, will focus on the choice of relevant immune-related biomarkers to be tested in order to predict and overcome resistance to treatments in patients suffering from lung cancer. The Pioneer Project, supported by the French Research Agency, will illustrate this topic.

How modulation of immune status of tumors during immunotherapies fights cancer cells and the associated mechanisms of action
Why gaining insights in the immune contexture of tumors at baseline and in the course of clinical trials for immunotherapies is crucial for predicting response to treatment and for deciphering mode of action of resistance to treatments
How biomarker evaluation can impact immunotherapy drug development

12/17/2019

Risk Management in Medical Device Manufacturing

Having an effective risk management process adds value by decreasing the project risks and avoiding costly late-stage changes. Furthermore, a risk management process is also mandated by regulatory authorities in the US through the FDA CFR 21 Part 820, the updated European EU MDR/EU IVDR and the MDSAP, which covers markets such as Canada, Brazil, Australia and Japan.

There are several aspects of implementing an effective risk management process. A recommended first step would be to establish a risk management process including usable and operational templates so that the process complies with ISO 14971:2012 for the European market and ISO 14971:2007 for the rest of the world.

How to improve efficiency in controlling and managing complex data structures
How to secure and improve traceability
How to improve visibility and processes
How to secure a complete audit trail in one system

12/09/2019

Real-Time Premarket Approval Application (PMA) Supplements
Friday, 15th November, 2019 01:00 PM IST 10:00 AM PST

An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. Premarket approval requirements apply differently to preamendments devices, postamendments devices.

• History of PMA regulations.
• When to file a PMA.
• Who must file a PMA .
• Preamendments devices and PMA requirements.
• Types of PMA submissions.
• Contents of a PMA.
• PMA review process.
• PMA user fees, review times, review trends
• Pitfalls and common mistakes
• Resources for more information

For More Information Kindly visit www.biopractice.com.
Write to us at marketing@biopractice.com
We are available 24x7 at 1- 646-216-8860

Address

New York, NY

Telephone

+16462168860

Website

Alerts

Be the first to know and let us send you an email when BioPractice posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Practice

Send a message to BioPractice:

Shortcuts

Featured

Share

Share on Facebook Share on Twitter Share on LinkedIn
Share on Pinterest Share on Reddit Share via Email
Share on WhatsApp Share on Instagram Share on Telegram