Answers

GETTING STARTED

Welcome! We are glad you're here!

Are you a member or already have an account?

You can find the Sign In link in the upper-right corner of the website. The site will recognize your username (try your email), and you can use the forgot password link to reset it.

Still having trouble? Contact us and we can assist you.

Create an account

If you are not a current member or have not created a website account with us, we invite you to join RAPS.

Logged in? Now what do you do?

Update your profile:

Click on your name and select My Profile to update your profile information.
Click on Overview and add an image to your profile. This is a snapshot of your profile and membership.
Click on Account to update your profile information.

Access Regulatory Exchange (RegEx):

Click on Membership & Community and then Regulatory Exchange Online Community.

Access your Online University courses:

Click on Education & Training and then Learning Portal.

Purchase RAPS items:

Click on Store in the upper-right corner of the website.

Check out the RAC:

Select the RAC Credential to learn about the RAC and apply.

Select Upcoming Events in the upper-right corner of the website.

Browse around the site:

Take a look around by navigating through the site.
Check out our new home page for updates on RAPS, news, events, and more.

We would love to hear about your experience with our site. Please submit your feedback in our website feedback forum.

Need help?

If you need help at any time, please Contact us.

LOGGING IN/LOGGING OUT
Sign In

The login link is at the upper-right hand corner of the website. If you are not logged in and are trying to access members-only content, purchase an item or register for an event, access the online university, or accessing Regulatory Exchange (Regex), the site will provide a login page.

To log out, select Log Out in the upper-right corner. Be sure to log out when you are on a shared or public computer.

Login user interface elements

NOTE: On the new Raps.org website, users who have not yet logged in will be asked to reset their password. Follow the forgot password instructions to reset your password.

FORGOT/RESET PASSWORD
Logging into the new Raps.org website will require you to reset your password the first time you log in. For security purposes we forced a reset of all passwords on the new site.

Sign In Button at top of page

Reset your Password:

Select Sign In in the upper-right corner of the website.
Click on the Forgot Password link.
Enter the email address associated with your Raps.org account and click Submit.
If you do not get an email within 10 minutes, we may have an old email on your account. Contact us for assistance.

Forgot Password and Create an Account links

Enter your e-mail address to reset your password.

ALLOWING COOKIES
In compliance with EU GDPR regulations and for your security, the site will ask you to allow cookies. Cookies are required for our site for logging in, purchasing items, registering for events, and accessing gated content. We also use cookies for website statistics to assist us in making informed decisions about organizing the website. Please see our Privacy Policy for details on how we use cookies.

You will only need to click this once or every time your browser clears cookies or history.

Click Allow Cookies button to give consent for RAPS.org to store cookies

Click Allow Cookies button to give consent for RAPS.org to store cookies

ACCESSING/UPDATING ACCOUNT
RAPS maintains accounts for users who make purchases, members, and for people who conduct business with RAPS. We request that you maintain your contact information in your account profile so that you do not miss important communications, confirmations, and receipts from us.

Accessing Your Profile:

Login to RAPS.org.
Once you are logged in, you will see Welcome, <YourName> in the upper-right corner of the website.
Click on your name to go to your profile.

Profile Overview:

On your profile overview page, you will see a snapshot of your profile information:
On the left-hand side is your profile photo. You can add an image or select Edit to change the image on your profile.
In the middle section at the top is a number which is your unique ID (or member ID for members). Under that is your organization, address, and email information.
If you have a current RAPS membership, you will see your member type listed. Those who are employees of Enterprise Members will see Receives Membership Benefits.
At the bottom is your choice to opt into the membership directory.
In the right -hand column of your profile if there are open balances to be paid they will be listed with links to pay them. If you are 90 days or less from your membership expiration date you will see a Renew button for easy access to renew your membership.

Updating Contact Information:

Select the Account tab on your profile, select Personal Info if it is not selected by default.
This form has all of the general profile information. Fill out missing information and click Save at the bottom.
Select Contact Info to update your address, phone, email, and websites.
1. Adding/Updating Addresses:
  1. The Addresses tab lists any addresses in the profile. Users can have as many addresses as you would like.
  2. Select Edit beside the address to change it, or Add New Address for a new one. Address types are Work, Home, and Other.
  3. The Primary address is used by default if Preferred Billing & Shipping are not selected.
  4. Show in Directory indicates if the address is shown in the directory listing.
  5. Linked means that the address is linked to your organization and will update within the organization record. You can remove this link it by selecting De-link when editing the address.
2. Update Phone Numbers:
  1. Select the Phone Numbers tab.
  2. Select Edit beside the phone number to change, or select Add New
  3. As with physical addresses, you can have multiple phone numbers associated with your account.
  4. Phone types indicate the type of number it is such as mobile or work.
  5. Link to Organization will automatically populate a phone number record that links to the organization record by default. Changes to those should be made in the Organization's main contact, or contact RAPS.
  6. Saving a phone number as Primary designates it the default contact number for your account.
  7. Show in Directory determines if the number will be shown in the member directory.
  8. The country field change will change the field size to allow for longer numbers and country codes for international numbers.
  9. You may delete numbers by selecting Edit and then Delete.
3. Update Email Addresses:
  1. Within Contact Info, select the Email Addresses tab
  2. Select Edit beside the phone number to change, or select Add New.
  3. If the email is used for login to the site it can be changed but cannot be deleted.
  4. Your Primary email address will be the default email used for informational emails, receipts, and other general correspondence.
  5. Show in Directory indicates that the email address will be shown in the member directory.
4. Updating Websites/Social Media Links
  1. You can have links to your social media accounts stored on your profile. To add or update, select Web Links within your contact info.
  2. When adding/updating a link, select the type of link (website, facebook, linkedin, etc.)
  3. Enter the proper URL and click Save.
5. Update Organization
  1. Currently, the website does not allow users to update their organization. Please Contact RAPS to request changes.

CHANGE PASSWORD
To change your password, you must be logged in. If you forgot your password, follow the forgot/reset password instructions.

Changing Password:

Click on your Welcome, <YourName> link in the upper-right corner of the website.
Under the Account tab, select Change Password.
Type in your old password and then provide a new password and re-type it to confirm. We recommend at least 10-character passwords, containing a combination of upper and lower case letters, numbers, and special characters.
Click the Change Password button to save your new password.

RENEW MEMBERSHIP
Members can renew their membership during the 90 days prior to their expiration date.

To Renew:

Log in using the logging in instructions.
Click on Welcome, <YourName> in the upper-right corner of the website to go to your profile.
On the overview tab, you will see a Renew button in the right column.
The renewal member types available with the same member type will be added to your cart automatically.
You can change your type by selecting Remove from Cart for the one that was automatically added and then selecting Add to Cart for the desired membership type.
If you wish to renew to a member type not listed, please contact us.
Select Review & Checkout.
Fill out your payment information and click Submit.
You will receive a confirmation email and a receipt email.

UPDATING ORGANIZATION
Organizations have their own record in our system that carries the organization's address, main email, etc. In order to add an organization to your profile, you need to LINK it to you. An organization that is LINKED to you is what displays on your profile. This linked organization is also the organization that will appear in RegEx. To add/update your organization, follow the steps below.

Accessing Your Profile:

Login to RAPS.org.
Once you are logged in, you will see Welcome, <YourName> in the upper-right corner of the website.
Click on your name to go to your profile.
On your profile overview page, select the Organizations tab
Select LINK ME TO AN ORGANIZATION
The system will automatically try to match you with an organization based on your email domain. If it does not find one, it will provide a search box to look up your organization. Select Not Listed Above if it does not find the correct organization.
If your organization is not found, select Not listed above and type in the name of your organization to be added to the system and Search. Add the organization by typing in the name and optional information in the next screen and Save. Your new organization is now linked to your record.
Once you find your organziation, click on the name to highlight the button and select Save.
It will ask you if you want to also link your address to the organization. This will link your address automatically to the organization's profile.
This will save your organization to your profile. That organization is what will now appear on your profile.

NOTE: If you link to an organization that has purchased a RAPS Enterprise membership, you will receive member benefits as a result of your employment with that organization. You will agree to RAPS membership agreement in such case. Learn more about Enterprise membership

BECOME A MEMBER
RAPS is a place for great networking, making invaluable connections, access to industry resources, and building a strong community for regulatory professionals. More than 16,000 of your colleagues are waiting to connect with you through our global network of chapters and local networking groups and via our award-winning, private online community: Regulatory Exchange.

Selecting Membership:

Select Join at the top right corner of the website.
Visit our Join RAPS page to learn about our different member types.
Select the + beside Show More Benefits to see the benefits for each of the member types.
Select Join Now beside the member type of your choice.
Select Create a Profile or Login if you have an account with RAPS already.
Select Add to Cart.
Complete your purchase.
You will receive a confirmation email. Welcome to RAPS!

UPDATING PREFERENCES
On every email we send, RAPS includes a link to manage your preferences. These preferences pertain to emails that are sent from RAPS directly. Preferences for RegEx communities are managed on your RegEx account at https://connect.raps.org. If you need any assistance, please contact us at raps@raps.org.

To manage preferences:

1. Select the link at the bottom of any email, or go directly to your preferences at https://www.raps.org/preferences

2. On the preferences page, all you need to do is provide your email, or you can log in if you have a RAPS.org account. Note, if you select the link from an email, your email may be pre-populated for you. If you are not in our system, a form will ask you to provide a few essential details about yourself.

3. The form will load any preferences you already have assigned and give you options to subscribe or unsubscribe to different categories. Select SUBSCRIBE or UNSUBSCRIBE beside any category. When you SUBSCRIBE, you will be asked to read and check the opt-in agreement.

4. To unsubscribe from all, select UNSUBSCRIBE ME on the last option on the form to unsubscribe from all emails.

5. Once you have indicated all of your preferences, select APPLY CHANGES at the bottom.

VIEW/PRINT RECEIPTS & CONFIRMATIONS
You can print receipts and confirmations of orders right from your profile. Note: Purchases will only be listed for any items purchased in 2018 and beyond. Please contact us for historical receipts.

Log into RAPS.org

Access your profile by selecting your name in the upper-right corner of the website.
Select the Purchases tab.

To Print Receipts:

Select Recent Payments.
Select Details by the payment you want to print a receipt for.
At the bottom, select Print.

To Print Order Confirmations:

You can do this two ways, you can select Recent Orders and select View and Print at the bottom.
Another way is to go to the type of item it is (for example, select Events on the left) and select Print at the bottom.
Note: Confirmations for items will be separated by product purchased.

Requesting confirmation e-mail for a purchase

HOW DO I GET TAX EXEMPT STATUS
You can identify that you are tax exempt on your profile. Use the instructions for ACCESSING/UPDATING ACCOUNT and select the Account tab on your profile, select Personal Info if it is not selected by default.

There is a line for your Tax Exempt Number. Once you enter a number, you will no longer be charged taxes for purchases.

ACCESSING ONLINE COURSES
Online courses or recorded webcasts are accessible through RAPS Online University.

You can purchase courses online and access them through the Learning Portal.

ACCESSING REGULATORY EXCHANGE (RegEx)
Access to the Regulatory Exchange (RegEx) Online Community is a benefit of membership. All users can view public information available on RegEx.

To Access RegEx:

Sign In using the login instructions.
Click on Membership & Community and select Regulatory Exchange Online Community or go directly to RegEx at https://connect.raps.org

WEBCASTS & VIRTUAL PROGRAMS FAQ

Registration

Online registration closes 24 hours prior to the live program. Afterwards, you can call the RAPS Solutions Team (+1 301 770 2920 ext 200) to register by phone up to the morning of the live program.

Cancellation/Refund

Cancellations must be received in writing by email to raps@raps.org by 5:00pm ET seven days before the webcast/virtual program. Refunds are subject to a 20% administrative fee. There are no refunds provided if the cancellation date has passed.

Access Information

Webcast/Virtual Program access instructions will be provided by email approximately two days prior to the live program. Alternatively, you can access this information anytime from your RAPS Learning Portal account.

On-Demand Access

All webcast and virtual program registrants will have access to the on-demand recording for up to one year. Registrants will receive an email with access instructions to the on-demand recording within 24 hours after the live program. Our webcast platform allows for viewers to submit questions for the presenters into the Q&A while watching the On-demand recording. Your question will be emailed to the presenter(s) and you will receive a direct response from them.

How to Access PDF Handouts/Sign in Sheet/On-Demand Webcast/Evaluation Survey/RAC Credit(s)

Everything related to your webcast is accessible through the RAPS Learning Portal. You must watch either the live or on-demand program and complete the evaluation survey in order to print your Documentation of Attendance for RAC credit(s). Please see link for more information: http://rapslearning.org/open/webcasts/Diagram.pdf

ONLINE UNIVERSITY FAQ

Access to Courses and Materials

Where are my courses?

Go to http://learningportal.raps.org/
Log in with your username/password (same login that you use for raps.org or RegEx).
In the menu click on "My Learning Activities"

What if I forgot my username and/or password?
No problem! From the RAPS.org or RAPS Learning Portal login screen you can update your username and/or reset your password using the links provided. If you continue to experience difficulties, contact the Solutions Center.

Can I access my online learning activities on a mobile device?
Yes. The RAPS Learning Portal is mobile-friendly.

Online courses are fully iPad and Android compatible; however, to complete the final assessment and submit the course evaluation you will need to return to the RAPS Learning Portal using a supported web browser (i.e., Chrome, Internet Explorer, Safari, Firefox).
*Using a mobile device with a screen smaller than a standard tablet (9.7”) is not recommended.

Enrollment Period

Will access be given to all courses at the time of registration?
Yes. You can access our learning products as soon as your purchase is confirmed. The courses will remain active under your account until 11:59 pm on the course closing date.

How long will I be able to access the course and supplementary materials?

Courses taken as part of the Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual) have a 12-month access period;
Those taken as part of the Regulatory Affairs Certificate: Medical Devices and/or Regulatory Affairs Certificate: Pharmaceuticals or as an upgrade toward the Dual Certificate have a six (6)-month access period;
Individual online courses and bundles have a three (3)-month access period.

Course and Supplementary Materials

Is it possible to get a hard copy of the lecture slides?
Unfortunately, we do not provide hard copies of the lecture slides. However, we do provide a framework of the courses in the form of supplementary materials. Also included are references and additional resources for your further information.

Final Assessment
Each course includes a cumulative final assessment, consisting of a randomized set of multiple-choice and true/false questions. An 80% or higher must be achieved on the assessment to pass the course. There is no time limit on the assessment and you may retake it as many times as necessary during your access period.

Please note that questions will change to include new randomized questions for each subsequent attempt.

*The Regulatory Affairs Certificate programs do not have a separate final assessment.

Selecting Courses

Do I need to take courses in specific order? Are there prerequisites?
No. There is no specific order to taking courses and no prerequisites are required. The courses you take will depend on your experience in regulatory affairs, as well as your personal goals. In fact, most of our courses are designed to cover a certain topic and can be treated as its own entity. It’s believed that a good foundation of the regulatory framework will be helpful and certain courses are a good start and help you lay a good foundation for future professional development. Please click here to view a list of courses that are considered “essentials” for regulatory professionals. Besides all “essentials”, you can also find recommended course packages based on a different focus of regulatory affairs, such as medical devices, pharmaceuticals, quality or clinical. In addition to taking individual courses, you can also earn a certificate by taking our pre-packaged bundles for medical devices, pharmaceuticals, or a dual program for medical devices and pharmaceuticals. Click here for more information and required courses to earn the above-mentioned certificate.

Do I have to finish one course to access the next course in the sequence?
No, you don’t have to finish one course to access another in most cases. As a general guideline, we recommend our users to finish the core courses before moving on to the electives because they provide a good foundation.

When do I choose all my elective courses?
We recommend that you select all your elective courses at the beginning of your study, but you can choose to complete the core courses first. You will have to select all of your electives before you begin. If you need to change your electives as you advance, we can accommodate your request to change electives.

If I take any course from the bundles offered, will it count towards my certificate?
Yes.

Up to four (4) Online University courses may be applied toward the Regulatory Affairs Certificate: Medical Device or the Regulatory Affairs Certificate: Pharmaceuticals program requirements.
Up to six (6) Online University courses may be applied toward the Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual) program requirements.

*The courses must be eligible for that Certificate program and have been completed within the past 18 months. The credit toward the registration fee and remaining course requirements will vary. Please contact the RAPS Solutions Team for more information.

Can I exchange Certificate Program Courses?
Yes, but must meet the following criteria:

Individuals with an active enrollment in a Regulatory Affairs Certificate may request to exchange an elective, provided the course has not been opened and has a “Not Started” status. Please note: After a course has been accessed it cannot be exchanged.

*The close date for the Regulatory Affairs Certificate will apply to the replacement course.

Extensions

Can I get an extension?
A one-time, 30-day complimentary extension may be granted for active courses. Requests must be received in writing at least one (1) business day prior to the course close date. If a course has passed its close date, requests for extensions and re-instatements will not be honored.

Additional access beyond the standard 30-day extension may be requested due to serious illness, injury or death and is subject to an administrative review. Contact the Solutions Team for assistance.

If additional access beyond the standard 30-day extension is requested and is not due to serious illness, injury or death such requests will be subject to an administrative review and a $25.00 per course processing fee will apply. Contact the Solutions Team for assistance.

Certificates of Completion and Transcript

How do I get my certificate?
You can get your certificate by logging into your account at http://learningportal.raps.org/, and then choose “My Account” by clicking on your name and then activate the “Transcript” tab.

Once the “Transcript” tab is activated, choose “Completions” to bring up all the courses you have competed. Click the printer icon to print your certificates.

Or if you want to print the completion record for all activities in your account, first activate the “Transcript” tab, then click on “Completions” and then click the “Print Transcript” button.

Do I get a certificate for each course?
Yes, there is a Certificate of Completion for all individual courses and for the Regulatory Affairs Certificate programs. However, if you have successfully finished all the courses required by any of our three certificate programs (Medical Devices, Pharmaceuticals, or Dual), you can request a certificate to be added under your account. In the meantime, you can print your complete transcript for individual courses from your account by clicking the “Print Transcript” button.

Customer Assistance

For account support or general questions, contact the RAPS Solutions Center
Email: raps@raps.org
Call: +1 301 770 2920, ext. 200 (8:30 am- 5:30 pm ET Monday through Friday)

For technical support, contact Conduent:
Email: knowledge.connection.help@conduent.com
Call: +1 877-399-4925 (9:00 am- 5:30 pm ET Monday through Friday)

RAC CANCELLATIONS, WITHDRAWALS & TRANSFERS

Cancellations, Withdrawals and Transfers

An application may only be withdrawn or cancelled before the application deadline of 1 March for the spring testing cycle, or 1 September for the autumn testing cycle. Requests to withdraw or cancel an application will not be accepted after this deadline. To withdraw or cancel an RAC application, you must submit a written request to the RAC program office at certification@raps.org. There is a $100 processing fee for withdrawn or cancelled applications.

A request to transfer to the next testing cycle may be made without charge before the application deadline of 1 March for the spring testing cycle or 1 September for the autumn testing cycle. Requests to transfer to the next testing cycle after the application deadline but before the end of the testing window will incur a transfer fee of $250. Transfers will be allowed up to 10 days after the end of the testing window (10 June for spring and 10 December for autumn). After this period transfers will not be allowed and applicants will be required to pay a new application fee at full price.

Under certain circumstances, as outlined below, the RAC program may, at its discretion, transfer an applicant's test to the next testing window and waive the transfer fee. If an applicant cannot take the RAC exam for one of the following reasons:

A documented, personal medical emergency
A death in your immediate family
Unexpected military deployment

The applicant may request to transfer to the next testing cycle. In such circumstances the applicant must contact the RAC program office no more than five days after the scheduled examination date (if a date has already been scheduled through the testing vendor). A personal medical emergency means that the candidate has experienced a medical issue. Transfer requests are not applicable for medical issues affecting family members. To apply for a transfer waiver the appropriate documentation must be submitted to the RAC program office no later than 30 days of your scheduled examination date. Only one emergency transfer will be allowed and candidates will not be eligible for a refund following a transfer. Work-related emergencies do not qualify for this exception.

RAPS CONVERGENCE CANCELLATIONS & SUBSTITUTIONS

Cancellation/Refund

All requests for cancellations and/or refunds must be received in writing at  raps@raps.org by 5:00 pm EDT on 17 August 2017. All refunds are subject to a 20% assessment. There are no refunds provided if the cancellation date has passed except for medical emergencies. In these cases, supporting documentation will be required in writing. Registrants who provide documentation of a serious medical emergency or death of an immediate family member may receive a refund minus a hundred dollar cancellation fee.

If an event is cancelled by RAPS a full refund will be provided within seven business days.

Substitutions

No substitutions are allowed and registrations are not transferable.

MEMBERSHIP FAQ

I just found out my company has an Enterprise membership. Can you refund my individual membership dues?

Any customer who works for a company that has an Enterprise Membership is entitled to a full refund of individual membership dues when a written refund request is received within one month of the customer’s individual membership start date.

Transfer & Cancellation Policy

Memberships are not transferable. Refunds for membership dues are not permitted after 30 days from the start date of the membership. For refund requests granted prior to the 30 day point a $50 processing fee will be assessed. If a company pays an individual’s membership dues, and it is within 30-days of the individual’s member start date than the refund will be issued to the company.

Any customer who works for a company with an Enterprise Membership is entitled to a full refund of individual membership dues when a written refund request is received within one month of the customer’s individual membership start date.

What is the Membership Agreement?

By clicking "Complete Order", I hereby confirm my purchase as selected and authorize RAPS to charge the disclosed fees to the credit card listed above. I've read and accept RAPS' cancellation policy. I understand that a condition of RAPS membership is my agreement to the RAPS Code of Ethics and agree to abide by the Bylaws of the Association. I also understand that as a member, I will have access to the RAPS membership directory which I will only use for networking purposes. I agree that I will not mine the directory for marketing or profiling.

By purchasing membership, I am opting in to allow RAPS to use my information for the purpose of doing business with RAPS. I consent that I am opting into the following of which I can opt out at any time by changing my preferences: a local RAPS community, member-related emails, a listing in the online member directory (profiles can be hidden), daily news in RF Today, the Under RAPS and Weekly Update member newsletters, and announcements of RAPS products and services. I understand that I may receive communications from RAPS that includes content from organizations that support RAPS activities. I also hereby understand and agree to the privacy policy provided on RAPS.org.

(Effective 5/11/18)

CHANGING YOUR CHAPTER
RAPS has multiple chapters and local networks available for members. You will automatically be assigned a chapter community on RegEx based on your primary address you provided. However, if you change locations, you can associate yourself with a different Chapter following the instructions below. If you need assistance, please contact raps@raps.org.

Changing Your Chapter:

1. Log into RegEx at https://connect.raps.org

2. Under the Communities tab, select My Communities.

3. The Chapter you are currently associated with is listed for you to select. Select the Chapter title to enter the community for that Chapter.

4. Select Settings in the upper-right-hand corner and select Leave Community to dis-associate with that Chapter.

5. To select a different Chapter, select Other RAPS Chapters or go back to RegEx Home and select Chapters. Select Join beside the Chapter of your choice to join that Chapter's community.

Displaying results 1-20 (of 21)

|< < 1 - 2 > >|

About the Regulatory Profession

Regulatory Code of Ethics

Member Knowledge Center

Regulatory Competency Framework

Regulatory Convergence

Fundamentals of US Regulatory Affairs, 10th Edition

Exam Schedules

Questions

Answers

Welcome! We are glad you're here!

Are you a member or already have an account?

Create an account

Logged in? Now what do you do?

Need help?

Registration

Cancellation/Refund

Access Information

On-Demand Access

How to Access PDF Handouts/Sign in Sheet/On-Demand Webcast/Evaluation Survey/RAC Credit(s)

Access to Courses and Materials

Enrollment Period

Course and Supplementary Materials

Selecting Courses

Extensions

Certificates of Completion and Transcript

Customer Assistance

Cancellations, Withdrawals and Transfers

Cancellation/Refund

Substitutions

I just found out my company has an Enterprise membership. Can you refund my individual membership dues?

Transfer & Cancellation Policy

What is the Membership Agreement?