Discover Top Posts Tagged with #regulatory training

Regulatory Training with MEMA

Ensuring FCA compliance is crucial for financial services firms. Our training guarantees that employees are competent in their roles, adhering to FCA rules on:

Attaining Competence

Maintaining Competence

Record Keeping

These principles help firms make informed HR decisions and identify compliance issues.

Ongoing FCA Compliance Support

MEMA offers tailored support for FCA-authorized entities to maintain compliance, providing services like documentation, ongoing advice, impartial monitoring, and more.

Why Choose MEMA?

Since 2019, MEMA has helped hundreds of businesses gain and retain FCA authorization. Our team, composed of ex-regulators, consultants, and specialists, offers expert solutions for complex regulatory requirements. We provide comprehensive support to develop your business model and ensure compliance.

For more information, Click here.

#Regulatory Training

ASSESSING REGISTRIES TO SUPPORT DRUG REGULATORY DECISION-MAKING

The Cures Act of the 21st Century, enacted on December 13, 2016, aimed to expedite the development of medical products and facilitate quicker and more efficient delivery of innovations and advancements to patients in need. One of its additions was section 505F to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In compliance with the stipulations in section 505F, the FDA established a framework for the Real-World Evidence (RWE) Program, which assesses the potential utilization of RWE to aid in the approval of a new indication for a drug previously sanctioned under section 505(c) of the FD&C Act.

Read more at : https://lnkd.in/g4bgzuEK

#easy global training #FDA #afsaneh motamed khorasani #Regulatory training

EUDAMED Register - OMC Medical is primarily based in the UK with offices around the globe offering regulatory support to medical device manufacturers; Offering assistance starting from medical device design requirements. https://omcmedical.com/eudamed/

#Regulatory Training #Premarket Notification 510(k)#eudamed register #eu classification of medical devices #De Novo Request #Global Language Translation #Software as a Medical Device(SaMD)

Medical Device Consultancy - We provide high quality work with low fees comapred to competitive rates in the market. UKRP, Regulatory Intelligence, Regulatory country submissions, Labelling and Art work, Global Language translation, SaMD (Software as a Medical Device), Regulatory strategy, Design to Sale regulatory assistance, Regulatory Training, Database Maintenance, Regulatory staffing-Interim and Permanent.

#EU MDR #Clinical Evaluation #Regulatory Strategy #Regulatory Training #Regulatory Intelligence #Regulatory staffing

Clinical Evaluation- We have a team of experts specialising in Medical Engineering, Software as a Medical Device (SaMD) with several years of medical device regulatory industry experience.

We give excellent work low expenses compared to serious rates in the market. https://omcmedical.com/services/

#CE marking #Clinical Evaluation #Medical Device Consultancy #Regulatory Training #Regulatory Strategy

OMC Medical help all clinical gadget associations from new businesses to global associations with financially savvy administrative arrangements. We have specialists from computer field to help Software as a Medical Device (SaMD), Biomedical Engineers with clinical gadget information and industry experience.

#Clinical Evaluation #Regulatory Training #Software as a Medical Device(SaMD)

Current Status of biosimilars in US, Europe and Canada

Overview:

Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.

Finally, we will address Europe and where the landscape is in terms of approval and market accessibility. We will address an interchangeability study ongoing in Denmark and new legislation in France using public policy to drive use of biosimilars. We will address upcoming patent losses, and what is known about current development of new biosimilars. Why should you Attend:

Understanding this fast developing area is critical. How will approvals be handled. Will indications be able to be bridged from a clinical study in one therapeutic area to another. Will interchangeability be recognized? How are some products / companies being successful? These are all questions in this complex landscape. We will address the current thinking on each and provide an update in terms of what is being done by whom in terms of development in this area. Areas Covered in the Session:

Biosimilar legislation in the US

Purple Book

Marketing applications filed using the biosimilar route or other routes

Interchangeability requirements

Status of subsequent entry biologics in Canada

Review of two products that have been successful in Canada by two different routes

Existing guidelines in Europe

Review of approvals in Europe

Interchangeability for infliximab in Denmark

Public policy driving biosimilars in France

Ongoing development work on biosimilars worldwide

Who Will Benefit:

CEO

Marketing director

New Business Director

Regulatory Affairs Director

Research Director

Clinical Director

Nonclinical Director

Speaker Profile:

Anne Tomalin

has practiced exclusively in the area of regulatory affairs since 1971. She has a strong background in business, government, regulations and reimbursement policies. Anne is a graduate of York University, and holds a B.A. degree in English (1970) and a B.Sc. degree in Chemistry (1980). Anne has received a Regulatory Affairs Certification from the Regulatory Affairs Professional Society for US Regulatory Affairs (1997), European Regulatory Affairs (2001) and Canadian Regulatory Affairs (2005). Anne founded Therapeutic Products Inc. in September 2013. TPIreg is a Regulatory Affairs boutique firm specializing in Canadian Regulatory Affairs.

Contact Detail:

Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected] http://www.compliance4all.com/ Event Link : http://www.compliance4all.com/control/w_product/~product_id=500684LIVE

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#regulatory training #Interchangeability requirements #Biosimilar legislation in the US