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UPCOMING EVENTS

NCRAF's Spring Summit will have a return engagement by former FDA Commissioner

Dr. Robert Califf

 

Wednesday, May 17, 2017

See details.

 

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RAC(US) Workshop Seminar Series
Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm

Location: DCRI, The Lower Level Conference Room (NOTE: This is NOT the Downtown Office)

See Here for Details

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RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

Click to see details

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

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RAC EU Workshop

NCRAF sponsors study group sessions for the Regulatory Affairs Certification (RAC) examinations for the US, Canadian, and European Union regulations, all of which are given annually by the Regulatory Affairs Professional Society (RAPS). Information on the RAPS certification exams can be found at the RAPS Web site.

NCRAF's training is designed to help NCRAF members prepare for the exams through lectures on regulatory policies and procedures, and by encouraging interactions amongst the study group participants. The EU RAC study group for winter/spring is scheduled to help participants prepare for the April RAC examinations.

 

The 2017 NCRAF EU RAC workshop will only have pre-recorded lectures.  They will follow the chapter order of the RAPS Fundamentals of EU Regulations textbook and will be made available to workshop registrants to select at their convenience. The site will be open on or about February 7th. There will be no live lectures for this workshop. 

 

If you are planning to take the EU RAC exam in 2017, purchasing the Fundamentals of EU Regulatory Affairs, published by RAPS is highly recommended.   PLEASE BE SURE TO NOTE ABOVE WHETHER YOU PLAN TO ORDER Fundamentals of EU Regulatory Affairs when you complete the registration form. The textbook is $300.00

 

 

Register Now!

 


NOTE: You MUST be an NCRAF Member to attend the study sessions. If you are not a member, please join by filling out the online Membership Application.

 


 


Registration

Any NCRAF Member may register for the one or more of the European Union (EU) study sessions. Any single topic is an excellent continuing education opportunity for anyone interested in understanding some aspect of the EU regulations, and the ten week session is a valuable preparation course for those interested in sitting for the EU Regulatory Affairs Certification (RAC EU) examination.

To cover the cost of study materials:

  • the cost of the 10-week series is $50, or
  • you may pay $15 for any single session.


If you have questions, please email the RAC EU study coordinators or call (919) 668-8032.

 

Additional Details

The cost of the RAC exam (administered by RAPS) is not included in the study group fee. Please see the RAPS Web site for registration information, including exam costs and locations.  If you are planning to take the RAC exam, purchase of the Fundamentals of EU Regulatory Affairs, 6th Edition (2012) published by RAPS, is highly recommended.

If you have no immediate plans to take the exam, the suggested readings and course materials will supply sufficient background.

 

Syllabus

Syllabus is flexible, based on the needs and interests of participants and the availability of speakers. The following is the 2014 syllabus which provides the types of topics covered in the workshop.

DATE

WEEK

SUBJECT

6th EDITION FUNDAMENTALSTEXT CHAPTERS

 

7 Jan 2014

1

  • EU Regulatory Affairs- An Historic Perspective
  • Enforcement and National Authorities
  • Overview of Authorization Procedures for Medicinal Products; Health Technology Assessment
  • Common Technical Document

 

1

7

17

4

 

14 Jan 2014

2

  • Medicinal Product Clinical Trials
  • Pharmacovigilance

18

25

 

21 Jan 2014

3

  • Generic Medicinal Products
  • Nonprescription Products
  • Reimbursement in the EU
  • Quality Systems and Inspectorate Process—Medicinal Products
  • The European Medical Devices Legal System

21

22

3

20

 

8, 12

 

 

28 Jan 2014

4

  • Medical Device National Particularities
  • Classification of Medical Devices
  • Technical Requirements for Conformity Assessment
  • Conformity Assessment Procedures: Quality System Requirements

Guest Speaker: Sandra Boyd, MBA, CQA, RAC

Biogen Idec: Corporate Quality, Standards & Compliance

16

9

10

12

 

4 Feb 2014

5

  • Clinical Evaluation of Medical Devices
  • Combination Products
  • Active Implantable Medical Devices
  • In Vitro Diagnostic Medical Devices
  • Medical Device Compliance: Postmarket Requirements

Guest Speaker: Sandra Boyd, MBA, CQA, RAC

Biogen Idec: Corporate Quality, Standards & Compliance

11

30

14

13

15

 

11 Feb 2014

6

  •  Notified Bodies

Guest Speaker: John Hille, Senior Project Engineer & Lead Auditor Underwriters Laboratories, Inc Underwriters Laboratories

 

 

18 Feb 2014

7

  • Registration Procedures for Medicinal Products
  • Pharmaceutical Postmarket Requirements and Compliance with the Marketing Authorization
  • The Paediatric Regulation
  • Friendly game to highlight key points

Guest Speaker: Asli Santos, PharmD, RAC

Director, Catalyst Regulatory Services, LLC

19

24

 

5

 

25 Feb 2014

8

  • Marketing Authorizations for Products Derived from Biotechnology
  • Scientific Advice
  • ATMP

Guest Speaker: Maria Oyaski, MS, MA, RAC(US,EU)

Regulatory Affairs Manager, Argos Therapeutics, Inc.

23

 

 

4 Mar 2014

10

  • Products Manufactured from Human Blood or Plasma
  • Human Tissue Regulation
  • Vaccines
  • Orphan Medicinal Products

Guest Speaker: Maria Oyaski, MS, MA, RAC(US,EU)

Regulatory Affairs Manager, Argos Therapeutics, Inc.

26

27

28

29

 

11 Mar 2014

11

  • Veterinary Medicinal Products
  • Cosmetic Products
  • Advertising and Promotion
  • Food Supplements, Health Claims and Borderline Issues
  • Crisis Management

33

31

6

32

 

2

 

18 Mar 2014

 

12

  • Wrap-up and Review