Regulatory Affairs Professionals Society (RAPS)

Our collaboration with DIA was such a great event last year, so we're hosting another one!

This December at the 2024 Regulatory Policy Forum, get ready for a highly-interactive summit where we'll explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena — including research, development and manufacturing — in Europe for decades to come.

Register before 18 October to save on this anticipated event: https://bit.ly/3XjUJr6

Don't miss your chance to learn lessons from eCornell faculty that you can use as a regulatory leader.

In this online program, you'll get expertly designed lessons in decision making, building better teams, leading with credibility and more.

And you'll get to work with regulatory professionals from around the world in a program that lets you fit your education around your life, instead of the other way around.

The deadline to register for the RAPS eCornell Regulatory Leadership Certificate is 4 October.

Secure your spot today: https://bit.ly/4dORYDR

What sessions are you excited for? Let us know in the comments 👇

And if you don't have your ticket to yet, there's still time to register!

Secure your spot at the biggest event in regulatory affairs today: https://bit.ly/3YKzHDa

🔥What's your hottest take about working in regulatory affairs?

A RAC is your ticket to standing out in the regulatory field.

A Regulatory Affairs Certification can help you gain credibility in your current role, and it can help get your resume to the top of a recruiter's pile if you're looking for a new one.

Register by 3 October to take your RAC exam this fall: https://bit.ly/3Mnu0mW

The FDA’s Quality Management Maturity Program continues to evolve in response to the escalating challenge of therapeutic drug shortages.

In this Regulatory Focus article, Robert Michalik, JD, RAC, and William Hauck, MSc, examine the rollout of the program and reports on results from the initial QMM pilot studies and industry stakeholders’ feedback, recommendations, and consensus opinions that informed the agency’s launch of the QMM Prototype Assessment Protocol Evaluation Program scheduled to begin later in 2024.

They also dive into the potential impact of the QMM program.

RAPS members get exclusive access here: https://bit.ly/3yD8wPN

Today's your day to save on regulatory career resources!

Save 30% on select RAPS books, Online University certificates and individual courses, and RAC Prep bundles today only!

This is our biggest sale of the year 😎

Shop today: https://bit.ly/3VHE3aM

Where collaboration reigns.

At Solutions Circles, attendees talk through regulatory scenarios and apply critical thinking in real time.

They're one of our attendee favorites for a reason. 😎

Get your ticket for RAPS Convergence today: https://bit.ly/3XfxbUg

P.S.: Registration rates go up on 28 August, so don't wait to get your ticket!

We're so glad to see the excitement around our new Collaborative Communities initiative. 💫

These new RAPS member-exclusive groups are here to let you explore the regulatory topics that interest you in an environment with others who share your curiosities.

If you're a RAPS member, you can join a group here: https://bit.ly/3VB6fgT

Making real connections in our field is so important. 🤝

We can't wait to re-connect with our regulatory community at .

Get your ticket here by 27 August to save on registration: https://bit.ly/3YKzHDa

For regulatory professionals, good communication skills go so much further than just sending emails to coworkers.

Regulatory professionals need to:

💡Write concise, clear messages
💡Hold effective meetings
💡Mediate disputes
💡Create documents that do not get them or their organizations into trouble
💡Make the most of their time with company executives

So that's what Nancy Singer and Robin Crawford-Kirschner are teaching in our RAPS Certificate in Effective Communication.

Each one of the five courses in this certificate program will focus on a topic mentioned above in an engaging environment that encourages sharing and discussion.

These courses are designed for regulatory professionals of all backgrounds and levels of experience, from regulatory newcomers all the way up to the C-suite.

Sign up today to get learning: https://bit.ly/3YHDC3m

Can you believe the world's biggest regulatory event is almost here? We asked a few of our speakers to share why they're excited.

See the full list here: https://bit.ly/4dlBTp9

This year's event in Long Beach is one you won't want to miss.

Got your ticket yet? Prices increase on 28 August, so don't wait!

We're teaming up with DIA to explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena — including research, development and manufacturing — in Europe for decades to come.

We're pleased to announce that registration is now open for the 2024 , an event from DIA and RAPS this December.

Learn more about this new event and get your ticket here: https://bit.ly/4dHSS4H

We're looking for regulatory professionals interested in sharing their knowledge in an interactive setting that's dedicated to regulatory at 2025.

You're invited to submit your presentation proposal for the biggest European conference in regulatory affairs by 20 September 2024.

Learn more about how you can submit your proposal today: https://bit.ly/3zyX5ZI

Our biggest sale of the year is coming 😎

Save 30% on select RAPS books, Online University certificates and individual courses, and RAC Prep bundles on Tuesday, 27 August.

Start browsing now: https://bit.ly/4cefY2l

Come learn from experienced regulatory presenters at one of our many online workshops this fall.

Each event is led by regulatory professionals who’ve chosen to share their time and expertise with our community in an interactive setting.

Explore the full schedule here: https://bit.ly/3PKFpPM

The pace of innovation in regulatory affairs doesn't show any signs of slowing down.

We asked a few of our 2024 presenters what they think is the biggest trend in regulatory affairs this year.

Here’s what they said: https://bit.ly/3Aa1ZwC

Drugs issued rare pediatric disease priority review vouchers that were redeemed had revenues that were similar to other brand drugs, according to recent research published in The Journal of Pediatrics.

Study: Drugs in rare pediatric disease priority review voucher program have similar revenue to brand drugs Drugs issued rare pediatric disease priority review vouchers that were redeemed had revenues that were similar to other brand drugs, according to recent research published in The Journal of Pediatrics.

The FDA has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph drug programs.

The rates are calculated by factoring in its resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.

Ferdous Al-Faruque has the details in Regulatory Focus: https://bit.ly/4d6MRym

FDA unveils FY 2025 user fee rates The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter monograph drug programs. The rates are calculated by factoring i...

RAPS Collaborative Communities are here.

These volunteer-led groups will allow regulatory professionals to have discussions on the topics that matter most to them — in an environment where other group members share their interests.

Join a RAPS Collaborative Community today. https://bit.ly/3VB6fgT

😎 2024 is halfway over. What are you most proud of so far this year?

📚 It's a new era for our regulatory books. Let us explain.

Today, we’re excited to introduce RAPS Library, a new technology that makes RAPS’ expert-written books more accessible.

We’re also debuting new subscription options to let regulatory professionals browse purchased books with ease, with the assurance they are accessing the most updated information available.

See how it can help you: https://bit.ly/3WSxog1

We're looking for regulatory professionals with experience with medical devices and biopharmaceuticals to join the RAPS Education Committee!

The RAPS Education Committee evaluates proposal submissions for RAPS education programs and makes sure our offerings are are suited to the needs of our members and the profession.

Learn more here: https://bit.ly/4di6lQo

We're looking for volunteers to help us with the RAC and RCC programs.

The Regulatory Affairs Certification (RAC) and Regulatory Compliance Certification (RCC) are RAPS' industry-leading credentials for regulatory professionals.

See how you can get involved: https://bit.ly/3Hp61SN

The FDA has warned Brassica Pharma for numerous good manufacturing practice violations, including multiple instances of employees falsifying sterility and environmental monitoring data and lax controls to prevent microbiological contamination. https://bit.ly/3A2nj7e

FDA finds data integrity, sterility problems at Indian drugmaker The US Food and Drug Administration (FDA) has warned Brassica Pharma for numerous good manufacturing practice (GMP) violations, including multiple instances of employees falsifying sterility and environmental monitoring data and lax controls to prevent ...

The FDA has finalized its guidance on evaluating real-world data from electronic health records.

The agency's final guidance offers additional clarification on selecting study variables and validation.

It alsoincludes recommendations for the use of quantitative approaches to aid in interpreting study results and analyzing potential misclassifications.

Ferdous Al-Faruque explains in Regulatory Focus: https://bit.ly/4bW7dsN

FDA finalizes guidance on RWD from electronic health records The US Food and Drug Administration (FDA) has finalized its guidance on evaluating real-world data (RWD) from electronic health records (EHR). The final guidance offers additional clarification on selecting study variables and validation and includes re...

Here's what your peers are learning so far in 2024 💡

Browse our catalog of more than 50 courses on regulatory essentials, medical devices, pharmaceuticals, quality, and clinical to find one that fits your goals: https://bit.ly/3LAkmwT