Clinical Research Staffing stock photo
March 11th, 2016

Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA

A Clinical Project Manager (part time contract) is needed for a Contract Research Organization (CRO) to work in their office in the Philadelphia area. This position will report directly to the Chief Medical Officer and includes responsibility for coordinating and managing all aspects of clinical study activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program.  Looking for Read the rest of this entry »

September 8th, 2015
Sample Clinical Trial Timeline used by Clinical Planning Manager

Sample Clinical Trial Manager Timeline

Sr. Clinical Planning Manager

Large Pharma Client Needs Your Clinical Trial Expertise!

A Clinical Planning Manager, capable of handling 12 teams with 25 members each of both internal and external members, is urgently needed by our client. You will use your 8 + years of industry experience to proactively identify potential pitfalls and steer the team around them. You will Read the rest of this entry »

October 17th, 2014

Outsourcing 101

  

You are Invited to the Joint Fall Conference 

 

Sponsored by

San Diego Regulatory Affairs Network (SDRAN)

and 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 19, 2014  Read the rest of this entry »

October 17th, 2014

Regulatory Inspections and How to Manage Them

You are Invited to an Evening Meeting

Regulatory Inspections
and How to Manage Them   

 

Orange County Regulatory Affairs Discussion Group (OCRA) 

 

Wednesday, November 5, 2014 

5:30 – 9:00 pm 

Read the rest of this entry »

October 17th, 2014

Precision  Medicine: A Medical Miracle or Ethical Nightmare?

The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician in the decision-making process. We will debate the concept of “hope” and “autonomy” and how it impacts patient/caregiver decisions regarding clinical trials when research subject is facing a life-threatening disease.Date(s): Nov 6 2014, 05:00 PM to 07:00 PM

Location: CareFusion Corporation Read the rest of this entry »

August 18th, 2014

Is it a Recall? Now what do we do?

Thursday, August 28, 2014
Noon – 5:30 pm   Read the rest of this entry »

July 22nd, 2014

Oncology Research Nurses (Contract/Perm)

Immediate need for experienced Oncology Research Nurses to work at a large clinical trial site in Los Angeles.

1) One Nurse is needed to fulfill a 3-4 month contract
2) Second Nurse is needed as a full-time direct hire Read the rest of this entry »

October 16th, 2013

Risk Management

Orange County Regulatory Affairs Discussion Group

Thursday, November 14, 2013

Location:

Irvine Marriott

18000 Von Karman

Irvine, CA  92612

949-553-0100   Read the rest of this entry »

October 10th, 2013

Clinical Trials 101

Joint Meeting with San Diego Regulatory Affairs Network

(SDRAN)

and 

Orange County Regulatory Affairs Discussion Group

 

Wednesday, October 30, 2013   Read the rest of this entry »

May 15th, 2013

Business Development Professional, Los Angeles CA

RESPONSIBILITIES
Qualified candidate should have a measure of success in building clinical trials services
• Establish new accounts
• Coordinate with Site Director to assure alignment between sales and execution of clinical trials
• Develop strategic alliances with large accounts
• Collaborate with CEO and Site Director to develop plans to expand into new therapeutic areas
MINIMUM EDUCATION/EXPERIENCE
• Bachelor’s degree in Business Management, Marketing or related field and at least five years related experience
Clinical Research Organization experience preferred OR
• Relevant sales of Clinical Research Services
Please contact:
~position closed~

May 15th, 2013

Sr. Manager/Director of Medical Education – Orange County, CA

As part of Global Medical Affairs, the Sr. Manager/Director of Medical Education is responsible for the successful execution of company Medical Affairs programs, including:

• Plan, manage and execute company’s New Customer Training and certification program worldwide, implement Staff and Surgeon training modules, develop strategies for training global field team.
• Associated to training and monitoring activities, the candidate will support implementation and execution of company’s podium and evidence plan, including:
o Planning, design, and execution of Read the rest of this entry »

April 11th, 2013

2013 Workshop – Marketing of FDA Regulated Products

FDA Centers, FDA Los Angeles District Office and the Orange County Regulatory Affairs Discussion Group Present The 16th Annual FDA-OCRA Educational Conference

June 12-13, 2013

Irvine Marriott
18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and OCRA, that affords you maximum interaction with both Los Angeles District and Washington-based FDA personnel. Over the years, the collaborative efforts of FDA and OCRA have brought FDA and Industry staff together for this Educational Conference.

Who Should Attend
* Regulatory Affairs/Compliance
* Clinical Affairs/Auditors
* Legal Staff
* Quality Affairs/Quality Control
* Marketing & Advertising
* Product Development
* Consultants & Analysts
* Operations & Management
Keynote Address:
What Went Wrong?
Tales from FDA’s Office of Criminal Investigations (OCI)
Special Agent Keith Hadley, from FDA’s Office of Criminal Investigations, will discuss criminal aspects of non-compliance.

Plenary topics:
* Food & Drug Administration Initiatives for 2013 and “Hot” Topics:
An Agency Perspective
* FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
* Border Protection: What happens if Your Product is Imported or
There are Suspicious Imports?
* Inspection Mitigation: Avoiding Escalation
* Business Disruption & Resumption Planning After a Disaster:
Real Life Experience and Agency Expectations
* Federal and State Marketing: Sunshine Laws
* Q&A Panel Sessions with all Speakers

Three Separate Breakout Sessions:
1. Medical Devices & IVDs:
* CDRH Update: Hot Topics, Changing Guidance & Expectations,
Partnering: The MDIC Experience
* Federal and State Marketing: Sunshine Laws
* UDI: Implementation and Impact on Industry
* Clinical Trials for Medical Devices: Key Priorities and Activities
* Case for Quality: What are Responsibilities of
Manufacturers/Distributors and FDA’s Next Steps
2. Drugs/Biologics/OTC/Generics:
* Marketing Applications: FDA Review Practices and
Preparation of Global CMC Submissions
* Generic Drugs and Biosimilars Update
* Quality by Design: How Well does Pharma Meet
Deming’s 14 Points?
3. Food/ Dietary Supplements:
* CFSAN and Industry Update
* GMP Issues: Updates, Inspections, Recent Enforcement Activity
* Labeling and Claims
* Dietary Supplements Case Studies and Expert Panel Discussion

Register Online
Be sure to log on or create a new user profile before registering
http://www.ocra-dg.org/

SCHEDULE

Wednesday, June 12, 2013

7:00 – 8:00 am
Registration and Continental Breakfast

8:00 – 8:30 am
Opening Remarks by Conference Chairs and OCRA President
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
8:30 – 9:20 am
Keynote Address:
Real Life Stories from FDA’s Office of Criminal Investigations
Moderator:
Regina O’Meara, Principal, Global IVD Regulatory Consulting
Speaker:
Keith Hadley, Special Agent, FDA’s Office of Criminal Investigations (OCI)
Agent Hadley will discuss criminal aspects of non-compliance.

9:20 – 9:45 am
Break

9:45 – 10:45 am
Food & Drug Administration Initiatives for 2013 & “Hot” Topics:
An Agency Perspective
Moderator:
Alonza E. Cruse, B.S., District Director, FDA Los Angeles District
Speaker:
FDA Speaker Invited
10:45 – 11:45 am
FDA and FTC Guidance on Social Media:
Innovative Marketing v. Control
Moderator:
Michael J. Wagner, Esq., Regulatory Counsel, Focus Diagnostics
Speakers:
FDA Speaker Invited
Eric Goldman, Professor of Law and Director of the High Tech
Law Institute, Santa Clara Law School
This session will cover the following on social media:
* Agency current expectations
* Status of FDA Guidance
* Tools available to monitor social media
* Online Accountability for manufacturers, distributors and packers
* Using Links on the Internet
11:45 am – 1:00 pm
Lunch

1:00 – 2:00 pm
Inspection Mitigation: Avoiding Escalation
Moderator:
Yasamin Ameri, RAC, Consultant, Quest International Consulting
Speakers:
Dr. Raymond W. Brullo, DPM, FAPWCA, Compliance Officer
FDA Los Angeles District
Jack Sorokin, Esq. Invited
This session will cover the following:
* Addressing potential findings during an inspection
* Responding to inspectional findings
* Meeting with the District
* Estimating Agency expectations and meeting them
* Not all inspections go smoothly and the are different levels of findings
* How does a firm ensure that corrective actions meet the FDA expectations and what are some practical tips for avoiding enforcement escalations

2:00 – 3:00 pm
Business Disruption & Resumption Planning After a Disaster:
Real-Life Experience and Agency Expectations
Moderators:
Esther Y. Kim, Esq, Director of Legal/Compliance, Pharmavite LLC
Del Stagg, PhD, Regulatory Affairs and Quality Consultant
Speakers:
Tanya Malais, National Emergency Response Coordinator, FDA
Robert Takemura, Partner, MLC & Associates, Inc.
This session will cover:
* Identifying potential disasters
* Business impacts following a disaster
* FDA expectations after a disaster

3:00 – 3:15 pm
Break

3:15 – 4:15 pm
Border Protection – What Happens if Your Product is Imported or There are Suspicious Imports?
Moderator:
Linda Hartley, Program Support Specialist, FDA Los Angeles District
Speaker:
Dan Solis, Director of Import Operations, FDA Los Angeles District

4:15 – 5:00 pm
End of Day Open Panel Discussion with All Speakers
Moderator:
James R. Lusk, RAC, Principal, Quality Systems International
5:00 – 8:00 pm
After Conference Reception
OCRA’s Member Appreciation Night
All attendees invited at no additional cost
Click Here to Download the Registration Form

SCHEDULE
Thursday, June 13, 2013
7:00 – 7:50 am
Networking Breakfast
Attendees will be broken into interest groups to discuss and strategize current industry challenges. We will have separate tables for the following groups:

* Medical Devices
* IVDs
* Drugs and Biologics
* Dietary Supplements

Note: The remainder of the day will be breakout sessions. There are three tracks to choose from:
Medical Devices and IVDs
Drugs, Biologics, OTC and Generics
Food and Dietary Supplements

Medical Devices and IVD
Breakout Sessions
8:00 – 9:15 am
Session #1: CDRH Update
Speakers:
FDA Speaker Invited
Mark DuVal, JD, President, DuVal & Associates
* Hot Topics
* Changing Guidance and Expectations
* Partnering: The Medical Device Consortium Experience

9:15 – 10:30 am
Session #2: Federal and State Marketing: Sunshine Laws
Moderator:
Elaine Messa, Director, Medical Device Quality Systems
Industry Speakers Invited
* What are Sunshine Laws?
* Reporting responsibilities of manufacturers
* Elements of marketing compliance plan
* What about the future and federal pre-emption?
* Covers marketing, sales and distribution
* Q & A
10:30 – 10:45 am
Break

10:45 am – 12:15 pm
Session #3: UDI (Unique Device Identifier):
Implementation and Impact on Industry
Moderator:
James “Rusty” Lusk, Principal, Quality Systems International
Speakers:
FDA Speaker Invited
Dawn Fowler, Sr. Manager of Global Labeling/Document Control,
Endologix
Everything you ever wanted to know, and more, about UDI
We know that:
* Not all suppliers are the same
* Not all manufacturers are the same
* Not all users are the same
* Not all points of use are the same

We also know that all the above and more, have a need to share the identical information across their points of contact. The UDI is the glue that binds the information into a format that is universally understandable and instantly available at all there interfaces.
Different needs may have different approaches:
* I have one high product. Why all the fuss?
* I have a bazillion sku’s- where do I start?

This session will cover:
* Format Options- why chose one over the other?
* General structure requirements
* Equipment Options
* Implementation successes and pitfalls
* Big Company versus Small Company approaches
* How much will this cost?

12:15 – 1:00 pm
Lunch

1:00 – 3:00 pm
Session #4: Clinical Trials for Medical Devices
Moderators:
Ginger Clasby, VP Clinical & RA, Transcend Medical, Inc.
Terrie Hopton, Mgr, Business Development, Promedica International
Speakers:
James R. Fleckenstein, Investigator, FDA, Los Angeles District
Christian Burns, Director, Clinical Operations & Marketing, ClinEdge
Lucinda Marinus, Clinical Data, Manager, Transcend Medical
Jodi Aiken, VP, Global Clinical Affairs, Transcather Heart Valve
Therapy, Edwards Life Sciences
In this session, we will discuss several key priorities and activities associated with planning and implementing medical device clinical trials, with an emphasis on:
* Unique considerations associated with finding and recruiting study subjects to participate in medical device clinical trials
* Considerations and best practices for collecting and analyzing clinical study data
* Risk-based monitoring of study progress and conformance with regulatory requirements

3:00 – 3:15 pm
Break

3:15 – 4:15 pm
Session #5: Case for Quality
Moderator: Eri Hirumi, RAC, Regulatory Affairs Manager, Beckman Coulter, Inc.
Speakers: FDA Speaker Invited
This session will cover:
* Background of the Initiative
* Why it’s important
* What are responsibilities of manufacturers and distributors?
* FDA’s next steps
Drugs, Biologics, OTC and Generics Breakout Sessions

8:00 – 9:30 am
Session #1: Marketing Applications: FDA Review Practices and Preparation of Global CMC Submissions
Moderator:
Cindy Fisher, PhD, RAC, Associate Director, Regulatory Affairs, Vical
Speakers:
Industry Speaker Invited
What does FDA look for in marketing applications? A CBER review team member will provide insights into how FDA reviews marketing applications and helpful hints on making your application process run more smoothly.
In today’s global economy, many companies are filing products internationally. With varying in-country requirements and varying IP protection around the world, what are the best practices for managing global CMC submissions?
This session is sponsored by the OCRA CMC Discussion Group.

9:30 – 9:45 am
Break

9:45 am – 12:00 pm
Session #2: Generic Drugs and Biosimilars Update
Moderator:
Michael A. Swit, Esq., Special Counsel, Duane Morris, LLP
Speakers:
FDA Speaker Invited
With the enactment of the Generic Drug User Fee Act (GDUFA), FDA’s Office of Generic Drugs (OGD) may finally have the resources it needs to address both the significant backlog in pending applications and the timelines for approval of generic drug applications. This session will explore how OGD is marshaling these new resources and dealing with other key issues evolving in the generic drug approval process, including citizen petitions challenging generic approval standards and a potential regulation that would impose new pharmacovigilance duties and labeling revision obligations on generic manufacturers. For anyone concerned with generic drugs, whether from a brand or generic perspective, this is an essential session.

12:00 – 1:00 pm
Lunch

1:00 – 4:15 pm
Session #3: Quality by Design (QbD): How Well Does Pharma Meet Deming’s 14 Points?
Moderator:
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
Speakers:
FDA Speaker Invited
Kevin R. Cahill, Executive Director, The W. Edwards Deming Institute
Ali M. Afnan, PhD, President, Step Change Pharma, Inc.
Michelle Howard-Sparks, Associate Director of Solid Formulations
Millenium Pharmaceuticals Invited
This session will delve into the application of W. Edwards Deming’s 14 Points for Management to the pharmaceutical industry. In the first half of the session, Kevin Cahill, VP of The Deming Institute and Deming’s grandson, will provide a primer on the Deming’s 14 Points and the philosophy behind them. The second speaker, Ali Afnan, will discuss the applicability and incorporation of Deming’s total quality management approach in the pharmaceutical arena.
In the second half of the session, the FDA will examine the application of statistical quality control techniques to ensure the quality of pharmaceutical products. Finally, an industry speaker will examine the incorporation of Deming’s concepts to the management of development and risk in a pharmaceutical setting.

2:30 – 2:45 pm
Break

QbD Session continues after the break.
Food/Dietary Supplements
Breakout Sessions

8:00 – 10:00 am
Session #1: CFSAN and Industry Update
Moderator:
Vicki Whitsitt, Mgr, Scientific/Regulatory Affairs,
Natural Products Association
Speakers:
FDA Speaker Invited
Cara Welch, PhD, VP Scientific/RA Natural Products Association
Michael McGuffin, President, American Herbal Products
Association (AHPA) Invited
This session will feature an update from FDA on industry hot topics their current priorities and hear from two industry associations address the challenges facing dietary supplement companies both on Capitol Hill and on the regulatory front. While GMPs continue to be in the forefront, it’s not just about GMPs – speakers will also touch topics such as adverse event reporting, the draft NDI guidance, FSMA proposed rules, import/exports, adulterated ingredients, etc.

10:00 – 10:15 am
Break

10:15 – 11:45 am
Session #2: GMP Issues
Moderator:
Timothy Stewart, PhD, Consultant, QSD Consulting Group
Speakers:
FDA Speaker Invited
Cindy Beehner, President, QSD Consulting
This session features an update from FDA on its recent GMP-related enforcement activities and inspection findings and insight from an industry consultant about addressing the most common problems and how to effectively respond to 483 observations.

11:45 am – 12:45 pm
Lunch

12:45 – 2:30 pm
Session #3: Labeling and Claims
Speakers:
FDA Speaker Invited
Industry Attorney Invited
Supplement labels and claims continue to be a concern to FDA and a source of numerous warning letters. Hear from FDA about the basic regulatory requirements for product labeling and claims for your products. The industry attorney will discuss how to properly position your product in the marketplace, discuss Prop 65 issues, and discuss how product labeling is causing companies to become part of class action suits.

2:30 – 2:45 pm
Break

2:45 – 4:15 pm
Session #4: Dietary Supplements Case Studies
and Expert Panel Discussion
All Speakers Are Asked To Join the End of Day Panel
This session will begin with a group activity of case studies on various scenarios related to current industry issues. The individual groups will share summaries of their case studies, and then it will be open to discussion from the group as a whole and input from the expert panel of speakers.

About OCRA
OCRA, Orange County Regulatory Affairs Discussion Group, is a non-profit volunteer organization composed of Regulatory Affairs professionals from the Southern California area who are interested in participating in educational programs and networking with one another. Our membership includes individuals who work in Life Sciences industries such as medical devices, pharmaceuticals, biologics, IVD, dietary supplement, food and cosmetics.

OCRA has over 850 members representing more than 225 companies in Orange County and surrounding areas. Our members represent companies of all sizes and complexities.

OCRA meetings provide an educational forum and a means for the regulatory community to network. While our focus is regulatory in nature, our programs have also provided timely information for individuals involved in Engineering (software validation and product development), Marketing (advertising and labeling), Quality (Quality System Regulation), and other related fields.

Gift Bag Giveaways and Sponsorships Available
Contact Kimberly Syre at ksyre@cox.net to inquire about sponsorship opportunities.

REGISTRATION INFORMATION
The 16th Annual FDA-OCRA Educational Conference
Applying Regulatory Science to the Marketing of FDA Regulated Products
June 12-13, 2013 at Irvine Marriott
For an Immediate Receipt, Please Use the On-Line or PayPal Option
http://www.ocra-dg.org/
REGISTRATION RATE
$ 725 OCRA Members
$ 775 Non-members (includes OCRA membership for one year)
$ 475 FDA/Government/Students*

ONE DAY RATE:
$ 425 OCRA Members
$ 475 Non-members (includes OCRA membership for one year)
$275 FDA/Government/Students*

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA.

INSTRUCTIONS TO REGISTER ONLINE:
Log onto the OCRA website (http://www.ocra-dg.org/) with your username and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

April 2nd, 2013

Building and Maintaining Quality in Clinical Trial Performance

FDA Inspections of Clinical Research Sites and Sponsors

Building and Maintaining Quality in Clinical Trial Performance

Wednesday, April 10, 2013

5:30 – 8:30 pm

Location:   

AMO Headquarters
1700 East St. Andrews Place
Santa Ana, CA 92705-4933

Program Managers:

Terrie Hopton, Manager, Business Development and Special Projects, Promedica International

Helene Spencer, Consultant, ClinReg Consulting Services, Inc.

Host: Tammy Vu, Regulatory Affairs Specialist, Global RA, Abbott Medical Optics Inc.

Schedule

5:30 – 6:30 pm      Registration and Networking Dinner

6:30 – 7:30 pm     

What FDA Looks for in Clinical Study Site Inspections

Speaker: Gene Arcy, Consumer Safety Officer and BIMO Inspector, FDA Los Angeles District

 

7:30 – 8:30 pm     

What Sponsors (and Sites) Should Be Doing to Assure Study Protocol and GCP Compliance

Speaker: Ginger Clasby, Vice President, Clinical & Regulatory Affairs, Transcend Medical Inc.

 

Synopsis:

The implementation and maintenance of high quality clinical programs is an expensive, time-consuming and hugely important activity for sponsors who will need study results for regulatory submissions or market expansion. Key factors include:

*   A variety of personnel, logistical and regulatory elements must be budgeted for, contracted and coordinated efficiently.

*   A thoughtful plan should be in place to recruit qualified study participations in a timely manner – and to keep them actively involved throughout their participation in the study.

*   Clinical data supporting study objectives must be captured and maintained in a manner that protects data integrity and is relatively simple for study sites to do.

*   A system should be in place to promptly and thoroughly evaluate and report safety events, as appropriate.

*   And, depending on the nature and duration of the study, there are the challenges of “cutting in” protocol modifications, managing changes in data capture requirements, study team turnover and the accompanying overall “study fatigue” experienced by study sites and sponsor work teams.

At this meeting, using a combination of didactic and case studies presentations, we will discuss best practices for clinical study start-up and ongoing implementation to ensure study quality and review how FDA inspectors confirm the adequacy of GCP and protocol compliance.

About the Speakers:

Gene Arcy has been an FDA Consumer Safety Officer for 13 years. HIs experience includes:

·    Biologics Specialist

·    HCT/Ps Inspection Program Monitor  (HCT/Ps = Human Cellular and Tissue-Based Products) for Los Angeles District (HCT/Ps regulated by CBER = Center for Biologics Evaluation and Research)

·    Medical Device Inspection Program Monitor (CBER approved/cleared devices only) for Los Angeles District

·    Also specialize in the inspection of tissue-based devices that have been cleared by CDRH, and conduct routine inspections of other non-tissue based medical devices (Not sure how you want to word this).

·    Performed Biomedical Monitoring (BIMO) inspections of clinical investigators under the GCPs to a large extent, and performed inspections of sponsor and  IRBs.  Also experienced conducting GLP inspections.

Gene has a M.S. in Quality Assurance-Manufacturing and served on Air Force active duty and Retired from the Air Force National Guard – Clinical Laboratory Supervisor.

Ginger Clasby has worked in the field of regulated medical products for more than 25 years. Introduced to ophthalmic devices when she began employment with American Medical Optics (AMO) in 1978, she worked with the company for nine years in various capacities as the companyʼs business expanded: Biostatistician, Quality Assurance Manager, Production Manager – Intraocular Lenses (IOLs), Manufacturing Engineering Manager, Plant Manager and Product & Marketing Manager – IOLs.

Subsequent to her employment with AMO, she joined the ophthalmic surgical products divisionʼs executive team at Optical Radiation Corporation (ORC). There, as Vice President of Sales and Marketing, she was responsible for worldwide marketing and domestic sales of the divisionʼs Class III ophthalmic surgical products for five years.

In 1994, she joined Promedica International, a specialty contract research organization (CRO). As a pivotal executive in this privately-owned firm, she built the companyʼs clinical regulatory division from ground up, establishing the organization as a respected, major provider of clinical research services within the ophthalmic and medical device market sectors. During her 15 year tenure there, she served as Vice President, Clinical & Regulatory and also as Executive Vice President, Business Development.

Ginger joined Transcend Medical in 2009. As Vice President, Clinical & Regulatory Affairs, she is responsible for overseeing clinical operations and regulatory processes associated with implementation and ongoing management of the companyʼs pivotal US IDE trial as well as additional trials underway in Europe.

She holds the MS degree in Industrial Engineering from Arizona State University and BS degrees in Mathematics & Physics from Guilford College. She is the current President of OCRA and serves on the University of California-Irvine Extension Life Science Advisory Committee and the California State University Program for Education & Research in Biotechnology Advisory Board.

Cost:

$50 OCRA Members

$100 Non Members

    (includes one year Membership to OCRA)

$25 Student/Government Rate
FREE for Abbott Medical Optics Employees

OCRA REGISTRATION INSTRUCTIONS 

FDA Inspections of Clinical Research Sites and Sponsors

Wednesday, April 10, 2013

 

Registration fee includes dinner, free parking at AMO and access to electronic presentations (if approved by speakers for distribution).    

 

Be sure to log on or create a new user profile before registering: http://www.ocra-dg.org/

 

MULTIPLE REGISTRATIONS:

Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address and credit card payment. Please let us know if you want us to process your credit card or hold it until we receive a check.  

Click Here to Download Event Flyer 

SINGLE REGISTRATION: Log on to the OCRA Web site with your username and password or create a new user profile: http://www.ocra-dg.org/

Once you are logged on, click on “Register for a Meeting” on the right-hand side of the page. Next click on the meeting for which you would like to register, then follow the online instructions. You will receive an immediate confirmation.

If paying by personal or company check:  Please register online, then fax your credit card details on your company letterhead to 949-266-8461 to hold your spot. Mail your check made payable to OCRA to the following address:    

Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046      Fax:     949-266-8461

Email: ksyre@cox.net

OCRA’s non-profit Federal Tax ID# 33-0630455

Payments and Cancellation Deadline:

For a refund, please cancel by emailing Kimberly Syre (ksyre@cox.net) by April 3, 2013. If you have reserved a space but do not attend, your payment MUST be remitted.

 

DRIVING DIRECTIONS:

Abbott Medical Optics (AMO)

1700 E. St. Andrew Place

Santa Ana, CA 92705

(714) 247-8200

Directions to AMO from Los Angeles International Airport:

– Exit the airport and follow the signs to 405 south (Long Beach)

– Continue on 405 for approximately 35 miles

– Take the 55 north and exit at Edinger Avenue

– Turn left onto Edinger

– Turn left on Lyon Street

– Turn left on St. Andrew Place and enter the first driveway on the right.

Directions to AMO from John Wayne, Orange County Airport:

– On exiting the airport, turn left onto MacArthur Boulevard

– Take the 55 north and exit at Edinger Avenue

– Turn left onto Edinger

– Turn left on Lyon Street

– Turn left on St. Andrew Place and enter the first driveway on the right.

It is recommended that you look up driving directions from your own starting point. 


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA  92612
Tel:    949-387-9046
Fax:    949-387-9047
Alt Fax:    949-266-8461
Email:    ksyre@cox.net

 

October 16th, 2012

The Difference Between Success and Failure in the Medical Device Business

Selecting Alternative Regulatory Pathways to Market

 

Orange County Regulatory Affairs Discussion Group


You are Invited to an Evening Meeting

The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market

 

Wednesday, Oct. 24, 2012


Time:  
       

6:00 pm – 8:00 pm  

  

Location:       

Alcon Laboratories
15800 Alton Pkwy
Irvine CA 92618

 

Presented by:

Evan L. Rosenfeld, MD JD FCLM 

Vice President for Medical and Scientific Affairs

Theorem Clinical Research

  

Program Manager: 

Christopher Swanson, Regulatory Affairs Specialist 

Advanced Sterilization Products 


Pricing: 

$50 OCRA Members 

$100 Non Members (includes OCRA Membership) 

$25 Students/Government
Free for Alcon Employees
(email Rob Fleming to be added to the list:
rob.fleming@yahoo.com)  

  

Synopsis of the Session:

The choice and availability of a more attractive, alternative regulatory pathway to the U.S. marketplace often can make the difference between a medical device manufacturer’s financial and market success or failure. Thus, a medical device sponsor’s essential business viability – or lack thereof – can depend directly on both the existence and the successful use of such an unconventional approach to FDA, especially for young companies in their early stages of business development.

In a 1997 law, the “de novo downclassification process” was created to assist companies to bring to market their new, novel, and by definition “Class III,” medical devices by allowing clearance under the much less burdensome 510(k) regulatory route, instead of having to go down the difficult route of premarket approval (“PMA”). Ultimately, the ability to submit a far simpler 510(k) premarket application rather than having to go the PMA route can reduce time to market entry by several years and decrease up-front monetary costs by literally hundreds of thousands of dollars. The de novo process allows FDA to more quickly and more simply clear a new device for sale on the U.S. market despite the nonexistence of a predicate device to which the “new” device might be found substantially equivalent and, thus, which ordinarily requires a PMA. The de novo process instead only requires the manufacturer to develop and implement certain, far less expensive “special controls” that better guide the consumer (including physicians and/or patients) that are aimed at enhancing overall patient safety and minimizing potential device-related dangers to the public.

The current presentation includes a brief historical overview of the de novo process and its evolution to present day, provides a summary of companies that have used the de novo process successfully, outlines the timeline for this process, discusses the changes to the de novo process that have been implemented most recently, and analyzes the benefits to and the challenges still facing the medical device industry’s use of the de novo downclassification route for product regulation and ultimate entry to the U.S. market. Also to be discussed are the Agency’s recent parallel activities to – on its own initiative – downclassify several device types, as support for FDA’s real moves to assist device manufacturers to move their innovative products more expeditiously through the market clearance process and onto the U.S. sales market.

About the Speaker:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research, Dallas TX 

Dr. Rosenfeld is in charge of leading the company in its efforts to assist clients with their complex strategic clinical study design, implementation, completion, and review/interpretation of such trial results, from the various perspectives of:
*  Optimizing regulatory pathways; Outcomes of governmental reviews for market clearance or approval; Post−clearance/approval market positioning (relative to potential and/or existing competitors); Long−term safety outcomes and assessments; and Overall scientific/clinical rigor of the clinical studies under advisement.

*  Involvement at all stages of clinical trials, ranging from first−in−man and feasibility studies (to confirm and support continued product development efforts) to post−market trials (e.g., to support reimbursement activities, ongoing safety and efficacy monitoring, etc.).

*  Involvement in all company business units, with predominant focus on medical device clients, including those with device−drug combination and in vitro diagnostic (IVD) products.

*  Providing senior oversight on large or complex ongoing projects to ensure quality, delivery and ongoing client satisfaction; Identify client needs and develop creative solutions for projects, leveraging expertise, operational capabilities and technologies.

* Maintaining a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * Building thought leadership by participating in conferences, events, and client presentations. * Leading client meetings, conduct capabilities presentations, and leverage personal networks and Business Unit expertise.

He has his MD from Medical College of Virginia, his JD from University of Pennsylvania Law School and a BA in Biology from Harvard.

 Click here to download the registration form 

REGISTRATION INSTRUCTIONS 

  

For an immediate receipt and confirmation email, register on line at OCRA’s website, http://ocra-dg.org.

  

If paying by personal or company check:

Please submit the online registration form. Mail your check made payable to OCRA to the following address:

 

Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047

Email: ksyre@cox.net

 

OCRA’s non-profit Federal Tax ID# 33-0630455

 

NOTE: We will ask for a credit card payment for any checks not received by the meeting date

Cancellation Deadline:

For a refund, please cancel by replying to this email by October 17, 2012

 

If you have reserved a space but do not attend, your payment MUST be remitted.

 

DRIVING DIRECTIONS:

Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618

 

   

It is recommended that you look up driving directions from your own starting point.  

 


Directions from LA:
Take I-405 S to Exit 3 (in Irvine).  Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.  Turn left onto Sand Canyon Ave.  Turn right onto Alton Pkwy.  Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.  The last intersection is Telemetry.  (If you reach Banting, you’ve gone too far.)

Directions from San Diego:
Take I-5 N to Exit 94B.  Take ramp right and look for signs for Alton Pkwy. Turn left onto Alton Pkwy.  Make a u-turn at Telemetry and arrive 15800 Alton Pkwy. (If you reach Banting, you’ve gone too far.) 

  


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461
Email: ksyre@cox.net

 

March 8th, 2012

Top 20 Skills You Need To Become An Effective Leader

Do you aspire to become a Executive Leader of Regulatory Affairs, Quality Assurance, Clinical Research, or Medical Affairs? Leadership skills for  are increasingly crucial given that you will have to set a course for an entire team, keep them all on track and keep them unified with your vision.

What you need and don’t have when it comes to leadership talent:

  1. Ability to balance work/life priorities
  2. Ability to learn new things quickly
  3. Ability to build and mend relationships diplomatically
  4. Ability to understand human nature through compassion, sensitivity and empathy
  5. Ability to remain calm and composed
  6. Ability to confront people
  7. Ability to work and adapt in a culturally diverse environment
  8. Ability to act decisively
  9. Ability to do whatever it takes to overcome challenges
  10. Ability to coach and develop people in their job
  11. Ability to recognize and reward people’s achievements
  12. Ability to direct and lead people
  13. Ability to facilitate and manage change
  14. Ability to network and promote one’s career
  15. Ability to listen and communicate information
  16. Ability to put people at ease
  17. Ability to work effectively with management
  18. Ability to respect diversity in the workplace
  19. Ability to be aware of one’s strengths and weaknesses
  20. Ability to visualize and plan objectives strategically

What would you like to do next?

  1. Submit my resume
  2. Learn about full-time recruiting services
  3. Speak with someone about my staffing needs
  4. See Staffing Capabilities
  5. Read other posts about Leadership Skills
  6. Read the entire report.
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