This seminar presents all the requirements to obtain FDA permission to market a Drug product in the USA. To find out the fastest and most cost-efficient way onto the USA marketplace this seminar is a must.
The Drug Approval Process: Preparation and Processing of INDs and NDAs - Hong Kong
l " Qetzealous
Knowledge. a Way FoIwaia. .
2-day In-person Seminar:
The Drug Approval Process: Preparation and Processing of
lNDs and NDAs
! 'lIF. “'(clII<! i : t-iuuiu
uI_Ii= i-qaiuif-i= i '. ».. '1.. «1t‘u-dill-l By: Albert Ghignone
Course "The Drug Approval Process: Preparation and Processing of runs and NDAs" has been presapproved by
RAPS as eligible for up to 12 credits towards a Dartii: Ipant'S RAC recemricaiion upon full cornplction.
About GlobaICompIiancePane| :
Glot)a| CompliancePane| is a trairilrig source that delivers diverse. high quality regulatory 2; Compliance trainings
These Iralrtinqs are Simple while being relevant and cost-effective while being convenient G| ot)alComp| iancePanel
imparts knowledge of best practices across a broad range of user—lriend| y mediums such as webinars. seminars.
conlerenccs and tailored. individualized consulting
Those help organizations and professionals implement compliance programs that meet regulatory demands and
put business processes in place Through our trainings. we bring together the regulators or experts on regulation on
the one hand. with the Community that needs to learn or be aware ofthose regulations. on the other
Our services benefit the Medical Devices. Pharmaceutical. Bio Technology Food Safety. Financial Accounl. ng
Standards. and IT Control Iii PCI lndustries Our clientele include. czonipanies such as J&. l, Pfizer Sanoli Aventis.
Pall Corp. Abbolt, l. ler(: k, Beyer and ROCHE}. SOVl’IE)()'Nl1ICl’lHI‘e Fortune 500 companies
Professionals who undergo trainings from G| obalComp| iancePane| exhibit .3 vastly improved quality of life in which
there is increased productivity and professional growth Some 30 000 professionals have gained from more than
500 training courses we have conducted till now
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i ‘i .1“: Global
2-day In-person Seminar 2014
This seminar presents all the requirements to obtain FDA permission to market a Drug product in the USA. To find
out the fastest and most cost-efficient way onto the USA marketplace this seminar is a must. This seminar
introduces FDA and its laws. regulations, policies and guidelines. Starting with Drug development this seminar
continues with discussions on the testing requirements for new chemical entities (NCE) and the IND system which
leads to Drug clinical testing. Discuss is the format and contents of an IND. All Phases of clinical testing are
covered - Phase 0. Phase 1. Phase 2, Phase 3 and Phase 4 testing Then the NDA system is addressed. The
format and content of an NDA are covered. The FDA submission review system is covered for lNDs and NDAs.
Also addressed are FDA post-approval requirements. With this seminar attendees get a better understanding of
the FDA Drug Approval Process and the underlying scientiﬁc and regulatory principles involved.
Why should you attend:
. Learn about FDA
- Learn about FDA laws, regulation. policies and
- Learn about the fastest and most cost—efﬁcient way
onto the USA marketplace
- Learn about Drug development
r Learn about the Drug approval process
- Leam about testing requirements for new Drugs
~ Leam about the IND process
~ Leam about format and content of an IND
- Leam about the NDA process
Day 1: Day 2:
Lecture 1: Introduction To FDA Lecture 1: Drug Clinical Trials
- History - FDA Clinical logicfrationale
- Laws - Phase 0 Clinical Studies
- Regulations ~ Phase 1 Clinical Studies
- Policies - Phase 2 Clinical Studies
- Overview of FDA
Lecture 2: Deﬁnitions
Lecture 3: Drug Classiﬁcation
- New Drug. Biologic or Generic Drug
- Drug status and strategy
Lecture 4: Drug Development Process
- Drug development outline
Lecture 5: lND Process
- IND format and content
- FDA Forrn 1571
- FDA mo submission review process
- IND amendments
- Phase 3 Clinical Studies
- Phase 4 Clinical Studies
LECIUFE 22 NDA PFOCESS
- NDA formal and content
- FDA Form 356(h)
- FDA NDA submission review process
- NDA amendments
Lecture 3: Post-Approval Requirements
- Requirements of the approval letter
- Registration/ Listing
- NDA Supplements
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a Knowledge, a Way Forwaiu, ,
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