Search Results for business

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EMA Plots Out Priorities to Deal With Brexit Uncertainties By Zachary Brennan - Published 16 October 2017

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Postmarket surveillance

Tags: Brexit, EMA business continuity

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

RAPS Executive Development Program Gives Regulatory Pros Needed Business Foundation By Zachary Brousseau - Published 07 April 2017

Increasingly, regulatory professionals are involved in making organizational business decisions, yet few have formal business training. RAPS' Executive Development Program was designed to help them hone their business, management and leadership skills.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Education, Career Development

Tags: Executive Development Program, executive, executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

Why Regulatory Professionals Need Business Training By William C. Putnam, PhD, RAC - Published 02 March 2017

Because regulatory decisions have a direct impact on business outcomes, regulatory professionals need to have a comprehensive understanding of business, such as the business acumen provided by extensive on-the-job training, professional development programs or formal business training.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Career Development

Tags: executive development, Kellogg, Northwestern, strategy, business, regulatory, training, education

EMA Explains How it Supports Article 58 Applications By Michael Mezher - Published 07 February 2017

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, EMA, WHO, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Article 58, Scientific Advice, Business Pipeline Meeting

Health Canada Details New Confidential Info Disclosures in Draft Guidance By Zachary Brennan - Published 14 March 2016

Health Canada is proposing to disclose more confidential business information (CBI) to eligible persons for the purpose of protecting or promoting human health or the safety of the public, according to new draft guidance.

Categories: News, Canada, Health Canada, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: Health Canada, confidential business information, confidential data

J&J’s Regulatory Executives Groomed as Business Leaders By Zachary Brousseau - Published 09 December 2014

J&J’s innovative AcceleRAte program grooms regulatory professionals to be the company’s future business leaders.

Categories: Under RAPS, Career Development

Tags: Johnson & Johnson, J&J, business, leadership

FDA Issues Guidance on Qualifying for Device User Fee Exemptions, Reductions By Alexander Gaffney, RF News Editor - Published 05 August 2013

Categories: US, FDA

Tags: Small Business, User Fee, MDUFA, Latest News, guidance, medical device

US Agency Launches Investigation Into Veterinary Pharmaceutical Industry By Alexander Gaffney - Published 29 June 2012

Categories: FTC

Tags: Competition, Anti-Competitive, Investigation, Veterinary, Latest News, workshop, business

FDA Releases Guidance on How to Qualify for Small Business User Fee Waivers By Alexander Gaffney - Published 31 May 2012

Categories: FDA

Tags: Small Business, User Fee, MDUFA, Latest News, Inspection

Brazil: New IVD Guidance Aims to Assist Small Businesses By Ansis Helmanis, RegLink - Published 29 May 2012

Categories: Regulatory Update, Anvisa

Tags: Small Business, brazil, IVD, guidance, medical device

Paper: Small Companies Need Regulatory Assistance from EMA By Alexander Gaffney - Published 13 March 2012

Categories: Meetings, EMA

Tags: Advanced Therapies, Small Business, Scientific Advice, CAT, Latest News, regulation, regulatory