Search Results for training

Showing 1 – 25  of 26

When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS By Zachary Brousseau - Published 05 October 2017

Pfizer partnered with RAPS to develop a customized on-site, two-day training session for several groups with different, but related, regulatory roles within the company.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: training, on-site training, Enterprise, Pfizer

ICH Details Pilot Training Programs for 2017 By Michael Mezher - Published 16 August 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: News, Japan, Europe, US, ICH, Clinical, Drugs, Manufacturing, Submission and registration

Tags: ICH, Training, eCTD, GMP, GCP

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

CDRH Seeks Participants for Staff Training Program By Zachary Brennan - Published 24 March 2017

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

Categories: News, US, CDRH, Combination products, In vitro diagnostics, Medical Devices

Tags: ELP, CDRH training, staff training FDA devices

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

FDA Calls on Pharma Companies to Join Manufacturing Inspection Program By Zachary Brennan - Published 15 November 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes.

Categories: News, US, FDA, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: OPQ inspections, FDA inspection training, CDER inspections

Novartis Signs up for Regulatory Training Program as FDA Looks for More Participants By Zachary Brennan - Published 07 April 2016

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is looking for additional participants for its Regulatory Project Management Site Tours and Regulatory Interaction Program as Novartis has already signed on to participate.

Categories: News, US, CDER, Audit, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: regulatory training, regulatory affairs, Novartis, FDA regulatory training

FDA Begins Training Hundreds of Indian Regulators By Zachary Brennan - Published 24 February 2016

The push to get India’s pharmaceutical and medical device regulators up to speed with international norms and the US Food and Drug Administration’s (FDA) regulations is progressing with new cooperative training sessions.

Categories: News, India, CDSCO, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: CDSCO, FDA training, FDA in India

FDA Lays Out New Areas of Interest for Training Device Review Staff By Zachary Brennan - Published 13 November 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia and health care facilities to participate again in a program that helps train medical device review staff.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Due Diligence, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDRH, IVDs, medical device training, device manufacturing

Out of Africa: Six Regulatory Articles that Span the Continent By Janet Aker, Managing Editor, Regulatory Focus - Published 16 February 2015

Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.

Categories: Features, Africa, Drugs, Government affairs, Project management, Submission and registration

Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante

Writing Skills for the Regulatory Professional By Mukesh Kumar, PhD - Published 28 January 2015

Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. This article is an introductory overview of his upcoming book and demonstrates that strong writing skills are a core competency of regulatory professionals.

Categories: Features, Communication, Medical writing, Project management

Tags: writing skills, technical writing, writing training

'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer By RS Robin Robinett, PhD - Published 27 January 2015

A flexible training methodology, referred to as the "cafeteria-style" approach, provides effective, efficient instruction for onboarding regulatory technical writers. This style of training is also useful in providing ongoing professional development for current staff.

Categories: Features, Communication, Medical writing, Project management

Tags: regulatory writing, training, regulatory technical writers, training buckets

RCOREs: African Regional Centres of Regulatory Excellence By Elias Nyberg, DVM, MBA, MRCVS, and Emma Burr Nyberg - Published 02 December 2014

African Regulatory Centres of Excellence (RCOREs) were mandated by the African Medicines Regulatory Harmonization (AMRH) initiative. There are currently 10 RCOREs throughout Africa. Their goal is to strengthen regulatory capacity development by providing academic and technical training in regulatory science.

Categories: Features, Africa, Government affairs

Tags: Africa, AMRH, RCOREs, regional centres of excellence, regulatory training

FDA Announces Major Regulatory Changes, With Specialization a Key Focus By Alexander Gaffney, RAC - Published 08 October 2014

Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of improvements to the way the agency is structured and regulates products.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Blood, Drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

Tags: PAG, Program Alignment Group, ORA, Office of Regulatory Affairs, Regulatory Specialization, Regulatory Training, Regulatory Education

FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics By Alexander Gaffney, RAC - Published 07 August 2014

The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates.

Categories: News, US, CDRH, In vitro diagnostics, Manufacturing, Medical Devices, Research and development

Tags: 3D Printing, 3-D Printing, ELP, Experiential Learning Program, General Training Program

FDA-Commissioned Report Makes Major Recommendations on How to Improve CDRH By Alexander Gaffney, RAC - Published 11 June 2014

US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says.

Categories: News, US, CDRH, Audit, In vitro diagnostics, Medical Devices

Tags: FDASIA, MDUFA, MDUFA III, Booz Allen, Report, Recommendations, Training, Regulatory Capacity

RAPS and China's SFDA to Collaborate on Regulatory Education and Training By Zachary Brousseau, RAPS senior manager, communications - Published 08 November 2012

RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US.

Categories: Under RAPS, China, RAPS, Education, Medical Devices

Tags: SFDAIED, SFDA, training

RAPS and China's SFDA to Collaborate on Regulatory Education and Training By Zachary Brousseau, RAPS senior manager, communications - Published 08 November 2012

RAPS and China's State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US.

Categories: China, RAPS, Education, Medical Devices

Tags: SFDAIED, SFDA, Latest News, training

Asian Regulatory Harmonization Plan Calls for Investments in Regulatory Capacity By Alexander Gaffney, RF News Editor - Published 25 October 2012

Categories: Asia

Tags: Asia Harmonization Working Party, Regulatory Capacity, AHWP, Latest News, training

FDA Looks to Support Animal Rule With New GLP Training Program By Alexander Gaffney - Published 15 June 2012

Tags: Biosafety Level 4, BSL-4, Good Laboratory Practices, Grant, GLP, Animal Rule, Latest News, study, training

EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations By Alexander Gaffney - Published 16 May 2012

Categories: EMA

Tags: Certified, Modules, Course, Dictionary, Eudravigilance, Latest News, certification, training

CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations By Alexander Gaffney - Published 10 April 2012

Categories: FDA, CDRH, Education

Tags: Risk/Benefit, Benefit:Risk, Benefit-risk, Learn, Module, application, Latest News, De Novo, PMA, guidance, training

FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products By Alexander Gaffney - Published 06 April 2012

Categories: FDA

Tags: Triad, Professional Disposables Incorporated, Sterile, Wipes, Recall, Latest News, manufacturer, Inspection, training

CDER Launches New Training Tool For International Regulatory Bodies By Alexander Gaffney - Published 27 February 2012

Categories: FDA, CDER, Compliance, Generic drugs

Tags: New Drugs, CDER World, Latest News, regulatory science, pharmaceutical, international, information, training

RAPS and Kellogg Offer 12th Year of Executive Development Program By Jay Haroon - Published 01 December 2011

The RAPS Executive Development Program will be held 11-14 June 2012. RAPS continues its successful partnership with the prestigious Kellogg School of Management at Northwestern University with a program designed specifically for senior-level regulatory professionals. The Kellogg School of Management is well respected throughout the business community. Business Week ranks the school third out of all US business schools while The Wall Street Journal puts it fifth on their list of best business schools in the country.

Categories: Under RAPS, Education

Tags: Executive Development Program, Executive, Kellogg, advancement, training