India’s Giancarlo Fisichella finish’s 2nd gets 8 points@ Belgium

August 30, 2009

India’s Giancarlo Fisichella finish’s 2nd gets 8 points – Gr8 Force India


2009 FIA Formula One World Championship Race Calendar

August 30, 2009

2009 FIA Formula One World Championship Race Calendar –http://www.formula1.com/races/calendar.html


Fisichella gives Force India first pole in Belgium

August 30, 2009

Giancarlo Fisichella took pole position for Force India ahead of Toyota’s Jarno Trulli and BMW Sauber’s Nick Heidfeld.

Fisichella had already been quickest for a while in Q2, but his 1m 46.308s had everyone gasping, especially when Trulli, who has been fast all weekend, came up short with 1m 46.395s as he edged out Heidfeld’s 1m 46.500s.

The Official Formula 1 Website


Attack on The Beach,Indira Nagar, Bangalore why?

August 29, 2009

Lets share and bring into notice of government


The (FDA) is proposing to amend its postmarket medical device reporting (MDRs) regulation

August 28, 2009

The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive.

Benefit/ Advantage

  1. Mandatory electronic reporting would improve the agency’s process for collecting and analyzing postmarket medical device adverse event information.
  2. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues.

FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation.

Date to Submit:

November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September 21, 2009.

Addresses to Submit:

You may submit comments, identified by Docket No. FDA–2008–N–
0393 and/or RIN number 0910–AF86, by any of the following methods

Electronic Submissions
Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments

Written Submissions

Submit written submissions in the following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA– 305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852

Instructions:

All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http:// http://www.regulations.gov, including any personal information provided.

Source: – http://edocket.access.gpo.gov/2009/pdf/E9-19683.pdf

Also I have found some webinars which are related to MDR medical device reports which can be helpful

  1. Complaint Handling, MDR’s & Recalls
  2. Medical Device Complaints, MDR’s and Recalls
  3. Development and Audit of Complaint Handling and MDR Processes

Source:- http://www.complianceonline.com


Put your mail on hold online

August 28, 2009

Whether you are on vacation or an unexpected business trip you can rest easy knowing your mail is safely held for you at your local Post Office.

  • This online service will electronically notify your local Post Office to hold your mail.
  • For same day service, online requests must be submitted by 2AM CST Monday – Saturday.
  • Mail can be held from 3 to 30 days.
  • We will resume normal delivery of your mail on the date you specify.
  • Online access to request this service is currently limited to certain ZIP Codes.

Click here


Pharmaceutical conferences 2009 September

August 27, 2009

Conference Name: The British Pharmaceutical Conference
Email: alyons@health-links.co.uk
Website: http://www.bpc2009.org/
Date: 6th September 2009 – 9th September 2009
Channel– Pharmaceutical

Conference Name: I22nd Annual European Haemophilia Consortium Conference 2009
Email: aiste@balticconference.com
Website: http://www.ehc2009.eu/
Date: 11th September 2009 – 13th September 2009
Channel– Pharmaceutical

Conference Name: 38th Annual Meeting of the American College of Clinical Pharmacology
Email: SUE@ACCP1.org
Website: http://www.accp1.org/cgi-bin/htmlos.cgi/001395.1.3318652372234802535/accp2007/subpage.html
Date: 13th September 2009 – 15th September 2009
Channel– Pharmaceutical

Conference Name: Twelfth Annual Land O’Lakes Conference on Drug Metabolism/Applied Pharmacokinetics
Email: jedemuth@pharmacy.wisc.edu
Website: http://www.pharmacy.wisc.edu/esp/drugmetabolismconference
Date: 14th September 2009 – 18th September 2009
Channel- Pharmaceutical

Conference Name: Computational Systems Biology and Dose Response Modeling Workshop
Email: jgalbo@thehamner.org
Website: http://www.thehamner.org/education-and-training/current-course-offerings.html
Date: 14th September 2009 – 18th September 2009
Channel– Pharmaceutical

Conference Name: 2009 PDA/FDA Joint Regulatory Conference
Email: neal@pda.org
Website: http://www.pda.org/pdafda2009
Date: 16th September 2009 – 18th September 2009
Channel– Pharmaceutical

Conference Name: Rosenšn Meeting 2009: DMPK Aspects of Drug Combinations
Email: jenny.hagberg@lakemedelsakademin.se
Website: http://www.swepharm.se/rosenon2009
Date: 17th September 2009 – 19th September 2009
Channel– Pharmaceutical

Conference Name: 8th Congress of the Baltic Association of Dermatovenereologists
Email: info@badv2009.com
Website: http://www.badv2009.com/home
Date: 17th September 2009 – 19th September 2009
Channel– Pharmaceutical

Conference Name: PDA Discussion Forum: Implementing Rapid Microbiology Methods
Email: info@pda.org
Website: http://www.pda.org/MainMenuCategory/GlobalEventCalendarandRegistration/European-Events/PDA-Discussion-Forum-Implementing-Rapid-Microbiology-Methods.aspx
Date: 21st September 2009
Channel– Pharmaceutical

Conference Name: Workshops on Concepts and Applications of Population based In Vitro – In Vivo Extrapolation of ADME Properties
Email: events@simcyp.com
Website: http://www.simcyp.com/ProductServices/Workshops/
Date: 21st September 2009 – 25th September 2009
Channel- Pharmaceutical

Conference Name: Handling Failures in Sterile Manufacturing
Email: stuermer@concept-heidelberg.de
Website: http://www.gmp-compliance.org/eca_seminar_6106.html
Date: 22nd September 2009 – 23rd September 2009
Channel– Pharmaceutical

Conference Name: Recent Developments in Wound Management: Intelligent Biomaterials to Novel Antimicrobials
Email: events@rpsgb.org
Website: http://www.rpsgb.org/pdfs/sciconf090924.pdf
Date: 24th September 2009
Channel– Pharmaceutical

Conference Name: GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
Email: bach@concept-heidelberg.de
Website: http://www.gmp-compliance.org/eca_seminar_6014.html
Date: 24th September 2009 – 25th September 2009
Channel– Pharmaceutical

Conference Name: Together! Cultural Connections for Quality Care at the End of Life
Email: conference@conlog.com.au
Website: http://www.conlog.com.au/palliativecare2009
Date: 24th September 2009 – 27th September 2009
Channel– Pharmaceutical

Conference Name: 1st World Conference on Physico-Chemical Methods in Drug Discovery and Development
Email: office@iapchem.org
Website: http://www.iapchem.org/
Date: 27th September 2009 – 1st October 2009
Channel– Pharmaceutical

Conference Name: Supporting Pharmacists in Delivering Enhanced Services
Email: events@rpsgb.org
Website: http://www.rpsgb.org/pdfs/sciconf090928.pdf
Date: 28th September 2009
Channel– Pharmaceutical

Conference Name: Property Measurement and Testing of Powders for Pharmaceutical/Neutraceutical Production
Email: wolfson-enquiries@gre.ac.uk
Website: http://www.gre.ac.uk/wolfsoncentre/events/pharmaconference
Date: 29th September 2009
Channel– Pharmaceutical

Conference Name: The QbD/PAT Conference 2009
Email: weidemaier@concept-heidelberg.de
Website: http://www.pat-conference.org/
Date: 29th September 2009 – 1st October 2009
Channel– Pharmaceutical

Conference Name: ICH Q7 Auditor Training Course
Email: ludwig@concept-heidelberg.de
Website: http://www.ichq7-week.org/
Date: 30th September 2009 – 2nd October 2009
Channel– Pharmaceutical