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 »

July 30th, 2015

Apprentices Available

Apprentices available to build a fresh new pool of talent in Quality, Regulatory, Clinical and Medical roles for Food, Biotech, Pharmaceutical and Medical Devices. Our grants cover part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years.  We currently have two 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 »

October 17th, 2014

The Reproducibility Crisis in Biomedical Research

New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research!

“The productivity of modern drug development has been steadily Read the rest of this entry »

August 18th, 2014

Secrets to Success: Pre-Subs, 510(k)s, and FDB

Wednesday, September 10, 2014 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 »

June 24th, 2014

BIOTECH PRIMER: CURRENT SCIENCE TRENDS, ISSUES, AND ADVANCES

June 30, 2014. 5:30 to 8:00 p.m. 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 7th, 2013

“Be in the know!”
Paper.li

Check out MEIRxRS’ new “quick read newspaper” and be in the know about what’s new in clinical research, regulatory affairs, quality assurance and medical affairs.

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

 

March 22nd, 2013

The 12th SABPA Education and Career Development Event 

When:  11:30 am to 2:00 pm, Saturday, April 6, 2013

Where: TBD

Registration: https://www.123signup.com/register?id=bcbsk

$10 ($5 student) until April 1st online; $20 onsite ($10 student onsite)

Weblink: http://www.sabpa.org/web/news_details.php?ID=457

 

Summary: Dr. Yuan Xu (VP, Novartis) and Mr. Brian O’Callaghan (CEO, Sangart) will discuss their career paths, views of leadership, and insights on the skills essential for anyone aspiring to achieve career success in the pharmaceuticals/biotech industry.
Speakers:

Yuan Xu, Ph.D.

Dr. Yuan Xu is currently the Vice President and Head of Biotherapeutics Development Unit located at Novartis La Jolla site. She previously served as Global Head and VP of Process Sciences, Production and Quality at Novartis Biologics, and VP and Site Head for Novartis Biologics at Basel Site from 2008 to 2011. Prior to joining Novartis, Dr. Xu held leadership positions, with increasing responsibilities, at several pharmaceutical and biotech companies including Genentech, GlaxoSmithKline, Chiron Corporation, and Amgen. Dr. Xu has worked on many biotherapeutics including various forms of antibodies, recombinant proteins, antibody-drug conjugates, therapeutic vaccines, gene and cell therapies. Dr. Xu has extensive scientific/technical expertise and development/regulatory experience with multiple successful biotech products including Activase, Pulmozyme, Rituxan, Herceptin, TNKase, Xolair, Raptiva, Avastin, Lucentis, Bexxar, Bacaplemin, Proleukin, Epogen, Enbrel, Prolia, Extavia and Ilaris. Dr. Xu did Postdoc training in Molecular Virology and Gene Therapy from University of California at San Diego Medical School. Dr. Xu has a Ph.D. in Protein Biochemistry from the University of Maryland at College Park and a B.S. in Biochemistry and Molecular Biology from Nanjing University in China.

 

Brian O’Callaghan

Mr. Brian O’Callaghan joined Sangart as President and Chief Executive Officer in June 2008. Mr. O’Callaghan brings a breadth of experience to Sangart, having held senior positions with a number of pharmaceutical and biotechnology companies in both Europe and the US. These include senior positions with Pfizer in the UK and Merck Serono in Germany, before becoming President and CEO of BioPartners, a Swiss based biotechnology company. Since relocating to the US, Mr. O’Callaghan has held senior management positions at Novartis, where he served as General Manager of their Transplantation, Immunology and Infectious Disease businesses, as well as at Covance, a clinical research firm, where he served as General Manager of their Cardiac safety and IVRS businesses. Mr. O’Callaghan joins Sangart from NPS Pharmaceuticals, where he served as Chief Commercial Officer. Mr. O’Callaghan brings his extensive general management background in the pharmaceutical, biotechnology and clinical research sectors, as well as his significant international experience, to lead Sangart through regulatory submission and commercial launch of MP4. Last October, Mr. O’Callaghan led a senior executive team to visit 9 Chinese companies in 5 cities to explore potential partnership opportunities.
Schedule:

11:30 am: Registration and Networking

12:00 pm: Light lunch

12:30 pm: Welcome & speaker introductions

12:40 pm: Presentations

1:30 pm: Q&A

January 3rd, 2013

OCRA Supplements Update: What’s on the Horizon in 2013

Orange County Regulatory Affairs Discussion Group (OCRA)

Wednesday, January 9, 2013
12:30 pm – 5:00 pm
Location:
Irvine Marriott
18000 Von Karman, Irvine, CA 92612
949-553-0100

Program Managers:
Rogelio Rodriquez

Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and Intellectual Property, Herbalife International of America

Vicki Whitsitt, Manager, Scientific and Regulatory Affairs, Natural Products Association

Schedule
12:30 – 1:00 p.m.
Registration

1:00 – 2:45 p.m.
Industry Update & What’s on the Horizon for 2013
Speakers:
Cara Welch, Ph.D., Vice President, Scientific & Regulatory Affairs, Natural Products Association (NPA)
and
Michael McGuffin, President, American Herbal Products Association (AHPA)
An industry update on regulatory activities that includes an update on current FDA activities including GMP inspections, GMP challenges with botanical dietary Ingredients & SAERs & a look at what’s ahead in 2013

2:45 – 3:00 p.m.
Break

3:00 – 3:45 p.m.
Testing and Laboratory Challenges
Speaker: Timothy Stewart, Ph.D., Consultant, QSD Consulting Group
Topics to Be Discussed:
1) FDA inspectors have developed and grown from entry level regulation curriculums. The harder questions are coming, how is your firm going to respond?
2) Specifications, raw material and finish product
3) Testing, raw material and finish product
4) Test appropriateness
5) Standards
6) Identification
7) Contamination
8) Sampling methods
9) Subset testing
10) What does that mean for your contract operations (manufacturing and laboratory)?
11) Qualified People
12) Corrective Action Reporting
13) OOS/OOT procedure
14) What does that mean for Quality Assurance and Regulatory Departments

3:45 – 4:30 p.m.
When to Call in the Experts
Speaker: Cameron Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs & Intellectual Property, Herbalife International of America

4:30 – 5:00 p.m.
Open Q&A with Speaker Panel
All presenters

Registration fee includes snacks, parking and access to electronic presentations (if approved by speakers for distribution).

About the Speakers
Michael McGuffin was honored in 2010 for over 20 years of dedicated service, having served as the President of the American Herbal Products Association (AHPA) and a member of the Board of Trustee’s for 10 years prior. He has been active in the herbal industry since 1974, having owned both retail and manufacturing businesses in this field.

A leading expert on dietary supplement regulation, Mr. McGuffin has been published in scholarly and scientific journals, including the Food and Drug Law Journal and Clinical Pharmacology & Therapeutics, and also wrote the highly-lauded publication AHPA’s Annotated Final Rule on Dietary Supplement cGMP (2007). Additionally, Mr. McGuffin served as Managing Editor of AHPA’s Botanical Safety Handbook (1997) and Herbs of Commerce, 2nd edition (2000). He speaks frequently on dietary supplement regulation in the U.S. and abroad.

Mr. McGuffin has represented the herbal industry at state and federal hearings on herbal regulatory issues. He has served as a member of the FDA’s Food Advisory Committee Working Group on Good Manufacturing Practices for Dietary Supplements (1998-99), the FDA’s Food Advisory Committee’s Dietary Supplements Subcommittee (2003-5) and currently serves on California’s Office of Environmental Health Hazard Analysis Food Warning Workgroup and the Advisory Board of the USC School of Pharmacy Regulatory Science Master’s Degree Program. He also serves on the boards of the American Herbal Pharmacopoeia, the American Association of Acupuncture and Oriental Medicine, and United Plant Savers.

Mr. McGuffin was awarded the Cliff Adler “Heart in Business” award in 1994 and the Nutrition Business Journal Award for Efforts on Behalf of Industry in 2004. Mr. McGuffin has been quoted in a variety of news publications such as the New York Times, the Washington Post, U.S. News & World Report and Newsweek and has made appearances on ABC’s Nightline, National Public Radio, and ABC Radio.

Cameron B. Smith, J.D., Senior Director, Regulatory, Government & Industry Affairs & Intellectual Property
Herbalife International of America
Cameron Smith has worked for Herbalife for eleven years and is one of the Company’s in-house attorneys. In addition to managing and protecting the Company’s intellectual property portfolio and handling a range of government-affairs responsibilities, he is the counsel of first resort for regulatory questions about foods, dietary supplements, and cosmetics, as well as product-related advertising and marketing issues. Admitted to practice in California, Louisiana, and Mississippi, Cameron earned his law degree at the University of Mississippi School of Law and his undergraduate degree at the University of Pennsylvania.

Timothy Stewart, Ph.D.,. QSD Consulting Group
Dr. Timothy Stewart is a retired professional athlete who became a scientist from University of Southern California. He has 10 years experience in oncology and chemistry laboratories using both modern instrumentation and classic compendia methods to bring better understanding of regulatory compliance to suppliers, manufacturers and marketers. Timothy has three years of experience with contract manufacturing of dietary supplements. Currently, he speaks, writes papers, audits, and works in a laboratory for the non-prescription drug, medical device, cosmetic, dietary supplement and food industries. He’s a consistent co-author for primary peer reviewed chemistry journals. In his spare time he can be found on the disc-golf course or riding waves in the ocean. You may view his profile at: http://www.linkedin.com/profile/view?id=48693551&trk=hb_tab_pro_top.

Cara Welch, Ph.D., Vice President, , Scientific & Regulatory Affairs Natural Products Association
Dr. Welch assists natural product industry members to implement policies in response to government initiatives in the regulatory and policy arena, and works with members of Congress and their staff, officials in the Food and Drug Administration (FDA), and other agencies whose actions have direct impact on the natural products industry. Additionally, she is responsible for advising association members on regulatory, safety, nutrition and health issues. Finally, she directs strategy development and provides guidance of the NPA Scientific and Regulatory programs, including the association’s Natural Certification for Personal Care and Home Care Products and Dietary Supplement GMP Certification.

Prior to joining the NPA, Dr. Welch studied at the department of Medicinal Chemistry at Rutgers University, under the direction of renowned plant biologist Dr. James E. Simon working on African botanicals and medicinal plants. She also studied with NPA Burton Kallman award winner Dr. Koji Nakanishi through the National Science Foundation’s Research Experience for Undergraduates (REU) award program. She earned her M.S. in Chemistry from the University of Iowa under Dr. James B. Gloer and her B.A. in Chemistry from Dordt College. She is a member of the American Chemical Society, American Society of Pharmacognosy and serves as a peer-reviewer for editorial boards.

Cost:
$135 OCRA Members
$185 Non Members
(includes OCRA Membership for one year)
$75 Student/Government Rate

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

Click Here to Download Registration Form for Fax Registrations

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.

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 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 January 2, 2013.

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

DRIVING DIRECTIONS:
Irvine Marriott John Wayne Airport
18000 Von Karman Avenue, Irvine, CA 92612
Phone: 949-553-0100

From OC/John Wayne Airport:
Exit airport on Michelson Drive. Go straight to Von Karman Avenue and turn Left onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Long Beach Airport
or LAX – Los Angeles International Airport:
Take 405 South (San Diego Freeway). Exit Jamboree and turn Right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.

From Ontario International Airport:
Take 10 West (San Bernardino Freeway) to the 57 South (Orange Freeway). Take 57 South to the 5 South (Santa Ana Freeway). Take 5 South to the 55 South (Newport Beach Freeway) and then to 405 South (San Diego Freeway). Exit Jamboree, turn Right off ramp. Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From Downtown Los Angeles:
Take 5 South (Santa Ana Freeway) to 55 South (Newport Beach Freeway). Take 55 South to 405 South (San Diego Freeway). Exit Jamboree and turn Right off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Diego:
Take 5 North (Santa Ana Freeway) to 405 North (San Diego Freeway). Exit Jamboree and turn Left off the ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.
From San Bernardino/Riverside:
Take 91 West (Riverside Freeway) to 55 South Freeway (Newport Beach Freeway). Take 55 south to 405 South Freeway (San Diego Freeway). Exit Jamboree Road, turn right off ramp. Turn Right onto Michelson Drive and Right onto Von Karman Avenue. Turn Right onto Quartz and Left at the stop sign. The Marriott Hotel is on the left hand side.

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

November 2nd, 2012

Quality in Performance Management

Today’s economic climate and competitive marketplace demand peak performance from everyone involved, and each individual, from the mail room to the CEO,  has the ability to affect change and drive business results. Join Gary Urban, Executive Director of Operations at Rx Research Services Clinical Research Organization (RxRS CRO) and explore his session on Quality in Performance Management to gain proven, holistic solutions to everyday performance management challenges.

Saturday, November 3rd

10:15am-11:15am

Kellogg West Conference Center
3801 W. Temple Ave. Building 76
Pomona, California 91768

Track Room 3

Register to attend the ASQ 5th Annual Southern California Quality Conference at https://www.cvent.com/events/Register/Waitlist.aspx

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

 

September 18th, 2012

SOCRA 21st Annual Conference September 21-23, 2012

 

Please join Rosemarie Christopher at the Society of Clinical Research Associates (SOCRA) 21st Annual Conference at the RIO All Suite Hotel in Las Vegas on September 21-23, 2012!

Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms are all invited to attend. Register now!

  • Stop by MEIRxRS Exhibit Booth #10 for some goodies : )
  • Listen to Rosemarie Christopher present how to Manage a Multi-generational Workforce on Sunday, October 23rd at 10:10am
  • Earn Continuing Education Credit Hours
  • Network with over a thousand industry professionals in CRO, pharmaceutical, device and biotechnology companies
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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