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Phase I Investigational Drug Products | USA Seminar 2018

Phase I Investigational Drug Products

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Who should attend?

Quality Associates or Specialists Regulatory Management or Regulatory Specialists Compliance professionals Quality Auditors Validation Engineers R & D Scientists- chemists, geneticists, biochemistry specialists, formulation chemistry Laboratory Personnel Senior Quality Managers, Quality VPs

Details

Overview:

In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211). There are certain requirements in 21 CFR Part 211 that are directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production and requirements as a result, are not appropriate to the manufacture of most investigational drugs used for phase I clinical trials. Based on these issues, application of cGMPs to Phase I investigational drug products was exempted from 21 CFR 211. However, based on statutory requirements as given in Section 505(i) of the FD&C Act, FDA issued regulations governing IND products in order to protect human subjects enrolled in clinical trials, specifically with regards to the chemistry, manufacturing and controls data submitted as part of IND applications for drugs or biological products.

Why should you attend:

FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA. If they review your IND and the appropriate information is not available to ensure FDA of the quality of the product, the IND will be placed on clinical hold, preventing your clinical program from going forward. 

Who will benefit:

  • Quality Associates or Specialists
  • Regulatory Management or Regulatory Specialists
  • Compliance professionals
  • Quality Auditors
  • Validation Engineers
  • R & D Scientists- chemists, geneticists, biochemistry specialists, formulation chemistry
  • Laboratory Personnel
  • Senior Quality Managers, Quality VPs

Speaker

Stephanie Cooke

President/CEO, Cooke Consulting Inc. 

Stephanie Cooke, is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms. 

 

Location:  Salt Lake City, UT Date: May 10th & 11th, 2018  and Time: 9:00 AM to 6:00 PM

Venue:  Hilton Garden Inn Salt Lake City Airport   4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

 

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Until March 31, Early Bird Price: $1,295.00 From April 01 to May 7, Regular Price: $1,495.00

Sponsorship Program benefits for “Different requirements for Phase I Investigational Drug Products” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901552SEMINAR?SEO

 

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Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until March 31, Early Bird Price: $1,295.00 From April 01 to May 7, Regular Price: $1,495.00

Contact

John Robinson
support@globalcompliancepanel.com

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