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Filtering on: "topics business skills"

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New Maryland Law to Restrict Generic Drug Price Increases By Zachary Brennan - Published 30 May 2017

A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact.

Categories: News, US, Biologics and biotechnology, Business Skills, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug prices, state drug price legislation, drug price increases, Nevada insulin

Senate Confirms Gottlieb as Next FDA Commissioner By Zachary Brennan - Published 09 May 2017

The Senate on Tuesday afternoon voted along party lines to confirm Dr. Scott Gottlieb as the next US Food and Drug Administration (FDA) commissioner.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Drugs, Government affairs

Tags: Scott Gottlieb, FDA commissioner, new FDA commissioner

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

Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April By Gloria Hall - Published 05 April 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.

Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices

Tags: Features, Regulatory Focus

Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts By Zachary Brennan - Published 27 March 2017

With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change.

Categories: News, US, Business Skills, Drugs, Government affairs

Tags: drug company profits, drug prices, R&D spending on pharmaceuticals

The Relationship Between Regulatory and Commercial Organizations: How to Work With Your Commercial Colleagues By Mary Ellen Cosenza, PhD, RAC - Published 16 March 2017

This article discusses why regulatory and business functions need to work together to ensure success in label development, launch, promotion and lifecycle management strategy and regulatory intelligence and provides successful partnership examples.

Categories: Features, Business Skills, Communication

Strategies and Tactics to Successfully Outsource Regulatory Work By Bill Snyder - Published 15 March 2017

This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing.

Categories: Features, US, Business Skills

Tags: Outsourcing, Performance Metrics

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

Is Regulatory Affairs Certification Right for You? By Zachary Brousseau - Published 06 February 2017

The decision to pursue Regulatory Affairs Certification (RAC) is a personal one with many variables to consider—from the amount of regulatory experience you have and the potential value of having the credential to how much time you can devote to studying. So while there is no one-size-fits-all answer to the question ‘Is the RAC right for me?,’ there are some important factors to take into account.

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

Tags: RAC, Regulatory Affairs Certification

Unifying Best Practices for Managing Regulatory Processes: Part 3 By Jim Reilly - Published 21 December 2016

This article highlights the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape as seen in the eyes of life sciences leaders who report their struggles in uniting disparate processes, systems and data.

Categories: Features, Business Skills, Project management, Regulatory strategy

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

The Evolving Role of the Regulatory Professional By Pallavi Trivedi MPH, RAC, Sharad Trivedi, MS, PMP - Published 28 October 2016

This article discusses the multifaceted role of regulatory professionals who must guide internal company functions from product formulation and analytical development, to manufacturing, supply chain, quality control, clinical and non-clinical science and statistics. The role includes understanding the changing regulatory environment, interpreting laws and regulations and generating relevant data to support compliance.

Categories: Features, Business Skills

Entering the China Market: Go-to-Market Strategies - Part 2 By Landon G. Lack - Published 23 August 2016

This is the second of a two-part series looking at best practices for medical device companies planning to enter the China market.

Categories: Features, China, Business Skills, Medical Devices

Reflections on Mergers and Acquisitions in the Healthcare Product Industry By Mark Gordon, MS, RAC, FRAPS, Sue James, RAC, FRAPS, Steven Knapp, MS, PharmD, Rosanne Yetemian, PhD, MSRS, RAC, Daniel G. Mannix, PhD - Published 18 August 2016

This article outlines critical process points, seven reflections from recent Merger and Acquisition (M&A) experiences and suggests best practices for optimizing M&A due diligence from several perspectives. In addition, the article offers insight and guidance on how to act, what to look for in due diligence exercises and what areas to further explore as one partakes in due diligence activities. The content was adapted from a session at the RAPS 2015 Regulatory Convergence in Baltimore, Maryland.

Categories: Features, Business and Leadership, Business Skills, Due Diligence

Tags: Mergers and Acquisitions, M&A, Due Diligence

Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? By Zachary Brennan - Published 17 August 2016

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process

RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role; Compensation Up By Zachary Brousseau - Published 17 August 2016

RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession.

Categories: HTML, Articles, Under RAPS, About the Profession, Career Development

Tags: Scope of Practice, compensation, salary, survey, 2016 Scope of Practice & Compensation Report

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016) By Nick Paul Taylor - Published 09 August 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Business Skills, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DCGI, insulin, RCGM, mAb, Asia Regulatory Roundup

The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role By Craig Gassman, MS - Published 28 July 2016

This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success.

Categories: Features, Business Skills, Submission and registration

Tags: Regulatory Information Management, RIM, Regulatory Operations

RAPS' First Chapter Celebrates 25 Years By Mary Meagher - Published 27 July 2016

The RAPS Bay Area Chapter is RAPS’ first, and will celebrate its 25th anniversary as RAPS celebrates its 40th during the 2016 Regulatory Convergence in San Jose, CA. We look back at the chapter’s origins, and at its current state as one of RAPS’ largest, most active chapters.

Categories: HTML, Articles, Under RAPS, US, San Francisco Bay Area Chapter, About the Profession, Career Development

Tags: RAPS 40th Anniversary, regulatory profession, San Francisco, Bay Area, Chapter

RAPS Members on the Value of Regulatory Convergence By Zachary Brousseau - Published 14 July 2016

We recently asked a number of RAPS members at various stages of their regulatory careers about the value of attending the Regulatory Convergence. Hear what they had to say.

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

Tags: The Regulatory Convergence, Regulatory Convergence, conference, annual conference, 2016 RAPS, #2016RAPS, San Jose

The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges By Joe Shepley - Published 12 July 2016

This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them.

Categories: Features, Business Skills, Drugs, Project management

Tags: Document Management, Process Mapping, Cloud

8 Networking Tips for Regulatory Convergence Attendees By Zachary Brousseau - Published 01 July 2016

RAPS’ Regulatory Convergence offers attendees more than educational sessions and workshops. A big part of the value of the Convergence—or of any conference—lies in its networking opportunities. To make the best impression you can, and hopefully build long-lasting, mutually beneficial relationships, there are a few networking basics you should keep in mind.

Categories: HTML, Articles, Under RAPS, RAPS Events, RAPS, Business Skills

Tags: Regulatory Convergence, 2015 Regulatory Convergence, conference, networking

219 Earned Regulatory Affairs Certification (RAC) Credential in Spring 2016 By Zachary Brousseau - Published 30 June 2016

More than 200 regulatory professionals attained Regulatory Affairs Certification (RAC) during the spring 2016 exam cycle. Earned by passing one of four exams, the RAC is the only professional credential for regulatory professionals in the healthcare product sector.

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

Tags: Regulatory Affairs Certification, RAC

Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June By Zachary Brousseau - Published 15 June 2016

RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time.

Categories: HTML, Articles, Under RAPS, RAPS, Career Search, Talent Recruiting

Tags: virtual career fair, regulatory career fair, career fair, regulatory jobs, regulatory job, jobs, job, regulatory career, regulatory careers, careers, career