Two In-Person 2-Day Workshops: 28-29 July and 31 July-1 August 2014
Workshop 1: Getting Products Approved by the US FDA: Drugs, Vaccines, Medical Devices, Dietary Supplements and Cosmetics (28-29 July, 2014)
Buenos Aires, Argentina
Course Description:
FDA has established specific regulations for each type of product it approves. Moreover, each product type presents alternative development pathways depending on the nature of the disease, the target population, etc. Though product development may seem a daunting task to those unfamiliar with the Agency, FDA provides clear guidelines in the road to commercialization. This workshop will provide insights into the types of applications received by FDA and outline regulatory requirements to be satisfied before market approval is granted. It will also describe advantages (such as expedited review and market exclusivity) that certain products may qualify for based on aspects such as indication, target population, etc.
Workshop 2: GMP Requirements for US FDA: Practical Suggestions for all Medical Products in the US Market (31 July-1 August, 2014)
Buenos Aires, Argentina
Course Description:
Manufacturing a drug product for the US market could pose a considerable logistical and financial challenge. FDA requires compliance with strict Good Manufacturing Practices (GMP). There are several basic GMP requirements that are common to most products such as drugs, biologics, vaccines, dietary supplements, herbals and cosmetics. By following some simple logical rules, manufacturers can assure FDA compliance. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing a product for the US market. The presenters will discuss key elements of GMP applicable to most FDA-regulated products such as managing the raw materials, process validation, batch records, testing for stability, shipping, labeling, and documentations. Issues specific to special products such as combination products, dietary supplements, diagnostic kits, and vaccines will be discussed. Perspectives for different classes of products will be presented using case studies.
Who will Benefit:
For additional information on the workshop agenda and logistics, please call: (54 11) 5180-4784 or email: [email protected]
Register for either or both the workshops by clicking below:
- Both workshops will be offered in English with Q&A in Spanish
- The workshop written material will be provided both in English and Spanish
Workshop 1: Getting Products Approved by the US FDA: Drugs, Vaccines, Medical Devices, Dietary Supplements and Cosmetics (28-29 July, 2014)
Buenos Aires, Argentina
Course Description:
FDA has established specific regulations for each type of product it approves. Moreover, each product type presents alternative development pathways depending on the nature of the disease, the target population, etc. Though product development may seem a daunting task to those unfamiliar with the Agency, FDA provides clear guidelines in the road to commercialization. This workshop will provide insights into the types of applications received by FDA and outline regulatory requirements to be satisfied before market approval is granted. It will also describe advantages (such as expedited review and market exclusivity) that certain products may qualify for based on aspects such as indication, target population, etc.
Workshop 2: GMP Requirements for US FDA: Practical Suggestions for all Medical Products in the US Market (31 July-1 August, 2014)
Buenos Aires, Argentina
Course Description:
Manufacturing a drug product for the US market could pose a considerable logistical and financial challenge. FDA requires compliance with strict Good Manufacturing Practices (GMP). There are several basic GMP requirements that are common to most products such as drugs, biologics, vaccines, dietary supplements, herbals and cosmetics. By following some simple logical rules, manufacturers can assure FDA compliance. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing a product for the US market. The presenters will discuss key elements of GMP applicable to most FDA-regulated products such as managing the raw materials, process validation, batch records, testing for stability, shipping, labeling, and documentations. Issues specific to special products such as combination products, dietary supplements, diagnostic kits, and vaccines will be discussed. Perspectives for different classes of products will be presented using case studies.
Who will Benefit:
- Directors
- Managers
- Supervisors and lead workers in Regulatory Affairs
- Quality Assurance and Quality Control
- Workers who will prepare GMP documents as well as those who will review these documents
For additional information on the workshop agenda and logistics, please call: (54 11) 5180-4784 or email: [email protected]
Register for either or both the workshops by clicking below:
Sponsors:
Group Registration (2 attendees) - Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - Workshop
$3,850.00
$3,850.00
Workshop - Product Code 2527
$420.00
$420.00
Single Registration - Adaptive Trials
$1,099.00
$1,099.00
Group Registration (2 attendees) - Adaptive Trials Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - Adaptive Trials Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - Adaptive Trials Workshop
$3,850.00
$3,850.00
Group Registration (5 attendees) - Adaptive Trials Workshop
$4,400.00
$4,400.00
Group Registration (6 attendees) - Adaptive Trials Workshop
$4,950.00
$4,950.00
Group Registration (7 attendees) - Adaptive Trials Workshop
$5,775.00
$5,775.00
Single Registration - FDA GMP Workshop
$1,099.00
$1,099.00
Group Registration (2 attendees) - FDA GMP Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - FDA GMP Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - FDA GMP Workshop
$3,850.00
$3,850.00
Group Registration (5 attendees) - FDA GMP Workshop
$4,400.00
$4,400.00
Group Registration (6 attendees) - FDA GMP Workshop
$4,950.00
$4,950.00
Group Registration (7 attendees) - FDA GMP Workshop
$5,775.00
$5,775.00
Single Registration - SOP Workshop
$1,375.00
$1,375.00
Group Registration (2 attendees) - SOP Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - SOP Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - SOP Workshop
$3,850.00
$3,850.00
Group Registration (5 attendees) - SOP Workshop
$4,400.00
$4,400.00
Group Registration (6 attendees) - SOP Workshop
$4,950.00
$4,950.00
Group Registration (7 attendees) - SOP Workshop
$5,775.00
$5,775.00
Single Registration - Technical Writing Workshop
$1,099.00
$1,099.00
Group Registration (2 attendees) - Technical Writing Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - Technical Writing Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - Technical Writing Workshop
$3,850.00
$3,850.00
Group Registration (5 attendees) - Technical Writing Workshop
$4,400.00
$4,400.00
Group Registration (6 attendees) - Technical Writing Workshop
$4,950.00
$4,950.00
Group Registration (7 attendees) - Technical Writing Workshop
$5,775.00
$5,775.00
Single Registration - FDA Inspection Workshop
$1,099.00
$1,099.00
Group Registration (2 attendees) - FDA Inspection Workshop
$2,200.00
$2,200.00
Group Registration (3 attendees) - FDA Inspection Workshop
$3,300.00
$3,300.00
Group Registration (4 attendees) - FDA Inspection Workshop
$3,850.00
$3,850.00