18th International Forum on Quality and Safety in Healthcare

Are you looking for an excuse to visit London? Don't miss the 18th International Forum on Quality and Safety in Healthcare.

2013 Forum Theme:  Improve Quality, Reduce Costs, Save Lives
When: 16-19 April 2013
Where: London

Now in its 18th year, the International Forum is an annual gathering of healthcare professionals in quality improvement and patient safety. The International Forum supports and energises the movement for healthcare improvement. This four day event connects healthcare leaders and practitioners worldwide to improve outcomes for patients and communities.

Jobs you may be interested in

Here are some jobs you may be interested in:

• Medical Director — Medical Safety Physician
• Chief Medical Information Officer
• Physician Informaticist
• Drug Safety Physician (Associate, Director)

Find more non-clinical physician jobs on the NonClinicalJobs Job Board.

FDA/DIA Statistics Workshop 2011

FDA/DIA Statistics Forum 2011

Date(s) And Time(s):  Apr 11 2011 8:00AM - Apr 13 2011 3:35PM

Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Statistics,Clinical Research,Professional Education, Training & Development,Clinical Safety/Pharmacovigilance,Medical Communications,Regulatory Affairs,Research & Development

Overview:
An Open Forum to Discuss Important Statistical Issues Associated with the Development and Review of Therapeutic Drugs and Biologics.

Don’t miss your annual opportunity to learn about and discuss the current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.

Complimentary McKesson webinar on FDA REMS

CBI's Complimentary Webinar: Submitting a Proposed REMS-- How to Comply with FDA Guidance

Sponsored By: McKesson

Date: Wednesday, January 13, 2010

Time: 12:00 PM - 1:00 PM ET 

Speakers:

• Ravi Deshpande, Pharm.D., Vice President Risks and Registry Solutions, McKesson Corp.
• Heather Morel, Vice President & General manager Reimbursement & Access Services, McKesson Corp.

In September, the FDA issued its draft guidance document "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." The document reflects the FDA's current thinking about REMS and provides initial guidance and templates for REMS submissions to the FDA. It is the first guidance provided by the FDA on REMS since the Food and Drug Administration Act of 2007 was enacted and is a critical document for pharmaceutical and biotech manufacturers to understand and integrate with its go-to-market strategies.

This webinar provides:

·         Third-party interpretation and perspective on FDA REMS draft guidance document

·         Tips on completing REMS submissions following the templates and guidance of the FDA and based on real experiences

·         Perspective of FDA trends and patterns in imposing REMS programs

·         Increased awareness of potential future intentions of FDA when it releases its final FDA guidance document on REMS in 2010

To register, please click here. For more information, please visit our website.

Who should participate:

Drug Safety Medical Affairs Pharmacoepidemiology Pharmacovigilance Safety Surveillance Risk Assessment Adverse Event Reporting Regulatory Affairs Risk Management Medical Product Safety Assessment Phase IV/Post-Marketing Studies

Health Outcomes Global Drug Safety Global Medical Affairs Clinical Affairs Scientific Affairs Product Management Clinical Development Product Safety Safety Scientists Medical Advisor

Physician careers in pharmaceutical medicine

I had a pleasant chat today with a physician who has been working in the pharmaceutical industry for several years. It was interesting to hear how he transitioned from the clinical world of academia to the pharmaceutical world.

You'll find all sorts of physicians who have built a career in pharmaceutical medicine. Some are in their thirties and skipped residency. Others transitioned into pharma while they were in their fifties. How do these people do it? You don't need an MBA to work in a pharmaceutical company. You also don't need to have a long list of publications. These things may help, but they are certainly not essential.

How many physicians do you know who currently work for a pharmaceutical company? What do they do? Are they involved in marketing? Clinical research? Health outcomes? Drug safety monitoring? Medical education? Public health? Pharmacoeconomics? Drug development? Regulatory affairs? Quality control? Medical affairs? Professional education and development? Medical writing? Managed markets? Managed care?

As a physician, there are so many possible career paths within the pharmaceutical industry. If you wish to learn more about some of these possible physician careers in pharmaceutical medicine, I encourage you to subscribe to my blog posts and visit this site frequently. The best way to learn is to hear some first-hand experiences from people who currently work in these areas.

Free Webinar on Observational Research

What do you know about the FDA Amendments Act of 2007 (FDAAA)? How about Risk Evaluation and Mitigation Strategies (REMS)? Here's a brief summary of this free webinar:

It has been generally assumed within the industry that the FDA Amendments Act of 2007 (FDAAA) would increase the number of observational studies required by the FDA to monitor the long-term, real-world safety of new products (whether as part of a Risk Evaluation and Mitigation Strategies (REMS) plan or as a standalone study). Based on the post-marketing commitments included in new product approvals over the past year, however, it is not clear where the FDA will ultimately settle regarding interventional vs. observational safety studies.

Complimentary Webinar:

Future Directions of Observational Research: What we expected or plotting a new course?
Jul 30, 2009
2:00 PM - 3:00 PM EDT

This webinar reviews the merits and strengths of observational research in terms of safety surveillance, real-world product effectiveness, patient-reported outcomes and health economic measures.

Presented by: Dave Provost; Vice President, Global Post-Approval; INC Research

Dave Provost is responsible for management of the operational unit as well as for providing strategic consulting to clients regarding the design and implementation of their global late phase programs. He has nearly 20 years of pharmaceutical industry experience, all within the peri- and post-approval areas, and offers deep expertise in program design and implementation strategies. In addition to clinical research, Provost also has a background in health outcomes, market research and data collection and presentation technologies.

Click here to register.

Medical Writing or Medical Blogging?

I often get asked, "are you a medical writer?"

Not technically. Well, maybe. I'm not sure. Yes.

I blog about medical stuff (mainly on MedicineandTechnology.com), so does that make me a medical writer? I'm definitely a medical blogger. What exactly is medical writing?

The world of medical writing is actually quite vast. Examples of writing projects include:

• Regulatory writing
• Protocols
• Proposals/grant requests
  
• Drug safety reports
• Marketing campaigns
• Ads and commercials
  
• Medical education
• Review articles
• Ghost writing (did I actually say that?)
• Abstracts
• Powerpoint presentations
• Manuscripts
• Medical transcription
• And yes, blogging
• Oh, this isn't a comprehensive list. There are many more items.
  

So, am I a medical writer?