OCRA eNEWSLETTER July 2005
Message from
the Editor
Ballots have been sent out for the 2005-2006
OCRA Board of Directors. Please complete
the ballot and fax it by July 15, 2005 to Kimberly Syre at 949-387-9047. As always, OCRA needs support to execute its
educational programs. Please show your
support by signing up to be a volunteer, which is a great way to get more
involved and achieve increased visibility in the Regulatory Affairs
profession. If you are interested in
being a volunteer for OCRA, just complete a
Volunteer Worksheet, which can be downloaded from the homepage of the OCRA
website and email it to ocra_news@ocra-dg.org or call or fax one of the OCRA Board members .
The 8th Annual FDA-OCRA Educational
Conference, co-sponsored by the FDA Los Angeles District and OCRA, was held on
June 14 and 15. With over 270 persons in
attendance, the conference was a great success.
Our thanks to Alonza Cruse and Chris Posin, who were
this year’s conference co-chairpersons for a job well done.
Congratulations to OCRA member George Sheaffer, Validation Technologies Inc. (VTI) for having his
company’s article (authored by Eugene Helsel)
selected for inclusion in the Regulatory Tidbits section of this month’s
newsletter. For this contribution,
George will receive a complimentary registration to a future OCRA meeting of
his choice.
Each month, OCRA will be offering an incentive
to encourage member participation in the development of the eNewsletter. One member whose contributing article or
tidbit is selected by the Editor for inclusion in the upcoming newsletter will
receive a complimentary registration to a future OCRA meeting of his or her
choice (Annual Meeting excluded). To be considered, all contributions must be
relevant to the Regulatory Affairs profession and must be submitted to the
Editor by no later than the 28th of each month. The author of the selected contribution will
be provided authorship with the contribution, which may be edited at the
discretion of the Editor.
All contributions should be submitted in MS
Word Format to pkramsky@eyeonics.com. No entries will be accepted after the 28th
of the month. So OCRA members,
show us your stuff and win a chance to attend a future OCRA program of your
choice – on our dime!
Thanks for your continued support and
commitment.
Paul Kramsky
Message
from the OCRA President
At our recent and very successful FDA-OCRA Educational Conference, “The Reality of Regulatory Affairs”, Alonza
Cruse, Director of the FDA Los Angeles District Office, gave us ten reasons to
attend the 2006 2-day meeting see below). I thought it might be
appropriate to give 10 reasons to be an OCRA member….
1. Ability
to communicate and collaborate with regulatory colleagues
2. An
opportunity to volunteer and share experiences
3. Forums
for networking and meeting with current and former colleagues – several meetings throughout the year
4. MDR
Network group
5. Risk
management for medical devices, pharmaceuticals, & biologics, group
6. Ability
to get reduced registration rates at some non-OCRA events due to OCRA collaborations
7. Preparation
courses for EU and U.S. Regulatory Affairs Certification
8. Low
membership fees (only $50/year)
9. A
resourceful website with job postings, website links, consultant listings, and program information.
(www.ocra-dg.org)
10. Ability
to receive this newsletter via e-mail
Have a Happy Summer!
Barbara Niksch
Message
from the FDA Los Angeles District Director
Top 10 reasons to
attend next year’s FDA/OCRA Educational Conference
·
Get to re-acquaint with colleagues;
·
It beats being
in the office;
·
At least you know where FDA is;
·
To overhear a
competitor idea and be the first to market;
·
To see who's
the new head of "this" at FDA;
·
To see just
how big FDA's 100th anniversary will be;
·
To keep
listening to the drumbeat (You had to be there);
·
My Boss thinks that I'm actually working;
·
To see how
many people have switched jobs;
·
I need to keep my souvenir bag collection going.
Alonza Cruse
Update on
Programs
Report
on the 8th
Annual FDA-OCRA Educational Conference (by Christine Posin)
Dr. Dan Schultz, Director of CDRH and Keynote
Speaker, provided a CDRH update on the strategic goals at FDA. We were honored to have Mark Elengold, Deputy Director of CBER, participate in the
Warning Letters session. This was his
last speaking engagement with the FDA – as he retired on July 1, 2005. He finished with a standing ovation from the
attendees. Other topics were Risk
Management and Assessment, Best Practices in Advertising and Promotional
Activities, and Failure Investigations and the CAPA Process.
On the second day, we started with four sets
of breakout sessions: Drugs, Devices, Biologics and IVD. These sessions addressed specific areas of
medical products, and allowed for a more personal contact with the many topic
experts who spoke in the sessions.
The conference was not without a little
excitement. We had a tsunami warning for
southern
Next year, the conference should be even
better – as the FDA is celebrating their 100-year anniversary. If you are interested in assisting with the
conference planning activities, please contact OCRA.
Upcoming programs (by Rusty Lusk)
JULY 16, 2005
Hiring Techniques AND Marketing Yourself
Learn the
competitive truths behind the real hiring practices of today's top
SEPTEMBER 10-15, 2005
The purpose of this
program is to guide the attendees through the RAC exam. This session, with the support of experts,
provides an excellent opportunity for the regulatory professional to gain
exposure to those industries for which they otherwise have little or no
familiarity. In addition, it offers a
helpful refresher to those who do not plan to take the exam but just want a
refreshment of knowledge in their industry.
Remaining
2005 calendar --
SEPTEMBER 21, 2005
INTERFACE BETWEEN
REGULATORY AFFAIRS AND THE PATENT PROCESS
OCTOBER 6, 2005
ASIAN UPDATE
NOVEMBER, 2005
REIMBURSEMENT
STRATEGY
For more
information on programs, go to http://www.ocra-dg.org/meetings.htm
Other meetings
To encourage a cooperative relationship
between Regulatory Affairs Professionals and Biomedical Engineers, ASME -
Bio-Medical Engineering Chapter of Orange County would like to invite you to
our event - Product Development and Rapid
Prototyping event at
For more
information, go to www.oc-bmec.org.
OCRA Networking Opportunities
Risk Management
Discussion Group (by Tania Hoffman)
With the issuance
of ICH Q8 Pharmaceutical Development and Q9 Quality Risk Management, and FDA’s
draft guidance on Quality Systems Approach to Pharmaceutical cGMPs, discussions
in Pharmaceutical Industry have turned to the concept of “Design Space.” This is the pivotal concept in FDA's effort
to integrate its pharmaceutical review and inspection operations into a new
"quality assessment" system.
"Q8" on pharmaceutical development indicates the expectations
for design space - demonstrating knowledge of critical quality attributes and
applying risk management to quality decisions.
The OCRA Risk Management
Discussion Group continues to discuss these new concepts in Pharmaceutical Risk
Management as well as issues surrounding Risk Management for Devices and
Combination Drug Products.
The Discussion
Group meets at Canon Medical Systems (
The next Drug and
Device Risk Management Discussion Group will be held on July 27, 2005 at Canon
Medical Systems (
Please send an
email to tbhoffma@USC.edu
and indicate your interest in attending the July 27 meeting:
Location:
Canon Medical
Systems
(Near the 405 fwy &
Date & Time:
Every last
Wednesday of the month
5:30 pm ~ 8:30 pm
If you have any questions, please feel
free to contact either Tania Hoffman or Tony Chan as listed below:
Tania Hoffman @ tbhoffma@USC.edu
Tony
Chan @ agsm_tchc@earthlink.net
MDR Network (by Christine Posin)
The topic of the July 6, 2005 meeting of the MDR
Network Group was “MDR Regulation: Back to Basics”. This presentation incorporated the plain
language MDR requirements recently issued and effective on July 13, 2005.
The MDR Network meetings are open to all those
who would like to attend. You do not
have to be a member of OCRA, and there is no charge for the meeting. Come join the group – and share your
experiences.
The MDR Network Group meets regularly. For more information, contact Christine Posin
(christineposin@msn.com).
FDA Guidances and International Standards (by Helene Spencer)
This week FDA posted the Q5E Guidance for Industry, Comparability of
Biotechnology/Biological Products Subject to Changes in Their manufacturing
Process. The International Conference on
Harmonization (ICH) recommended the guideline for adoption in November 2004
after it had reached Step 4 of the ICH implementation process. Q5E provides
FDA’s current thinking and recommendations about assessing “the comparability
of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance
or drug product” during development and after approval. The guideline was
written to assist manufacturers in providing evidence to ensure that such
process changes will not adversely affect the quality, safety, or efficacy of
the product.
The document can be
viewed at http://www.fda.gov/cder/guidance/6677fnl.htm
The GAMP Good
Practice Guide: Validation of Laboratory Computerized Systems provides a
harmonized overview of the key elements involved in the life cycle of
laboratory computerized systems, from initiation to retirement. The focus of
the Guide is on computerized laboratory instrumentation, data management, and
analysis systems. It is intended as a supplement to The Good Automated
Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in
Pharmaceutical Manufacture - GAMP4.
The scope of this guidance includes
laboratory computer systems used within the regulated healthcare industries
subject to good manufacturing practice (GMP), good laboratory practice (GLP),
or good clinical practice (GCP).
This GAMP Good Practice Guide
describes systems categorization and risk assessment processes which can be
used to determine a rational, scalable approach to the validation of laboratory
computerized systems, by building upon the GAMP 4 software categories.
This guidance may
be obtained from www.ISPE.org
Regulatory Tidbits
Review of the April 2005 Draft FDA guidance “
Contributed by
George Shaeaffer and Eugene V. Helsel,
III, RAC, Validation Technologies, Inc. (VTI)
Introduction and Background
This review
provides the reader with an analysis of the FDA draft guidance. The focus of
the analysis is the impact of the draft guidance on industry. In the Critical
Path Initiative Report (1) the Food and Drug Administration (FDA) explained
that new tools were needed to distinguish potentially successful early drug
candidates from those drug candidates unlikely to succeed. Success is measured
ultimately in terms of product safety and efficacy. Currently the vast majority
of investigational products that enter clinical trials (critical path) fail to
reach product launch. Product development programs must be abandoned because
key clinical endpoints were not met after extensive investment of time and
resources. This high failure rate drives up overall costs of healthcare.
Screening product
candidates prior to traditional clinical trials is a tool to increase the
probability of bringing a safe and efficacious product to the public and reduce
critical path failure. Exploratory investigational new drug (
The Draft Guidance
The draft guidance
(2) issued in April 2005 seeks to provide information for the preclinical and
clinical approaches that are to be considered when planning an exploratory
The guidance
discusses what information should be in the general investigational plan and
types of studies to consider for the clinical trial. The guidance also lists
the chemistry, manufacturing, and control (CMC) information that should be part
of the submission, and provides examples of the preclinical safety data needed
to support typical exploratory
The major benefit
of this draft guidance is that it clearly shows that there is less data
required from preclinical safety studies to support exploratory
References
1) Innovation or Stagnation, Challenge and
Opportunity on the Critical Path to New Medical Products, US dept of Health
and Human Services, Food and Drug Administration, March 2004
2) See Guidance for Industry, Investigators, and
Reviewers,