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The Drug Approval Process: Preparation and Processing of INDs and NDAs - Hong Kong


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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.

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The Drug Approval Process: Preparation and Processing of INDs and NDAs - Hong Kong

  1. 1. V 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. A-- 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 min-tiwns . ut-la . -H -e~--st»-r= i-'1:-i-: ><@>-l. 'l't-I1-i-eltq lrlflilllflslflzlvlslt
  2. 2. tgl‘. i ‘i .1“: Global E, :E;7CompliancePane| Overview: 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 guidelines - 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 Agenda: 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 Guidelines - 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 -iuwwne : tlI<i1._ I~V' = _-I-si~1=i-‘(ax-j>~Q~€it-1
  3. 3. it? -L‘ G! o I V ’ I . . a . £: F'; ’C<: mp| iancePane| I xetzealous a Knowledge, a Way Forwaiu, , GlobalCompliancePanel Seminar Registration Form Pricing “St: GROUP REGISTRATIONS Price for One Delegate pass Price: $1 ,595.00 Send Your Team for Maximum Benefit Get your team up to speed! 5 Attendees — Get 10% of! Register now and save(Early Bird) $200.(Early Bird) Price 3 to 6 Attendees — Get 20% off 7 to 10 Attendees ~ Get 25% 019‘ 10-» Attendees Get 30°/ D ofi "K’i‘sva<t~ ni-11+ ma FFIi‘l"'r‘ri"i‘| '7 . .., .w he i—. i.i: .=. « . ~ day’-. was h'n. iVs-; i'i'~r in the . ’i‘i—! 'é- 1! me i. ~mm». .» What you get Payment Options: Learning Oblectlves -: - Credit Card: use the Link to make Payment oy Participation certificates Visa/ Master/ American Express card click on the Interactive sessions with the US expert regster now lmk Post event email assistance to your queries §)lbbiVJ—- -: - Check Kindly make the check payable to Nellealous special price on iuture purchase oi web based DEA Globa| Corrip| ian(; ePane| and mailed to 161 trainings , Mission Falls Lane, Suite 216, Fremont, CA 94539. USA 5 Special price on iuture consulting or expertise SCFVICCS. , - PO: Please cirop an email to 7 special price on iuture seminars by G| obaICompliancePane| 8 Seminar Kit includes presentation handout. ID card, suppot-t@giobalcompliancepanel com or call the our toll free s1—ao0-447-9407 for the invoice and you brochure, trainings catalog. notepad and pen ma)’ '3‘ ""3 PO ‘° 302 288 685‘ 9 Networking with industry's top notch proiessiorials "' Wire T'3"‘5'9'3 M9359 d"°P 3" email ‘O support@globalcompllancepanel com or call our toll free ¢1»800—447-9407 tor the wire translcr lniorrnalion Contact Information: Event Coordinator Kindly get in touch with us for Toll free: +1 -800-447-9407 any help or information. Fax: 302 288 6884 Look forward to meeting you Email: suppoi1@gIobalcompliancepanel. com 3; me seminar Team GlobaIComp| iancePanel Netlealous LLC, DBA GIobaIOompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA ’I"'lV. 'A'n!
  4. 4. (GZ'g? na;3|iancePane| Knowledge. away Forward, G| obaiComp| iancePane| Seminar Registration Form Registration Form: Please use this forvn to register online. using your Amencan Express, Visa or MasterCard. To et discounts on fin? attendance lease call us on 41 -800-447-9407 Ca us on IBEIO 447 0 or lax your 0 to 302 288 6884 Please pay your check issued tram the payee to Netzeaious LLC. our parent company. and mail it to Netzealous. 151 Mission Fails Lana. suite 216. Fremont. CA 94539. USA Please call us at v1~aoo—447-9407 or email us at sup9od@g| obaicompI| ancepanei. com Please fill this iorm out and include attendee and payment details in ll and tax it to 302 255 6884 Terms and Conditions Your registration for this seminar is bound by terms and conditions spell out here. Please call or mail us if you have any clarifications or doubts on this issue. Cancellations and Substitutions it you wish to cancel your attendance at our seminar. the person who has registered lor this seminar has to submit written cancellations through tax or email at least 10 calendar days before the date at commencement oi the event This will entitle herlhirn to a full refund minus a $1 50 administration lee. No cancellation request will be accepted or entertained and no relunds will be issued lor requests made outside the stipulated period A request to this efieci has to be sent by email or tax more than ten days before the commencement date or the seminar Alter receiving this request. we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future G| obaICompiiancePanoI event, and 3 credit note will be issued towards this. You are allowed to make substitutions at any time till the start or the event The substituting person should be present well in time for the event with proper written communication and company identity. ll registering on the date oi‘ the seminar. please matte sure you pay lor the even! using your credit card or check just pelore the start 0! the event. To such attenaees. we may not be abie to give the oonrerenoe matenals on the spot. In such an event; we will send the same aiter the conclusion or the seminar. No-shows will not be reimbursed. ll GiclbalCompIianoePaneI cancels an event. we will not be reimbursing any airtare. accommodation. other costs or losses that the registrants may have Incurred. Glutialcompliancel= aneI reserves the right to change topics and speakers without notice. Seminar Topic Dalet. Attendee 1 : ' . Email Attendee 2 1 . Email . Attendee 3 : Email . . Attendee 4 : Email Payment Options E1 checit enclosed. payable in us. funds to Netzeelous LLC, DEA G| obaiConpilarlceFanei Company Information Organization . ... . . . Address . . Ei charge to' Clvlsa Eimastei-card EiAi-nertean Express C-fly __ credit card no. E i is d Country " c: /F: /an Dnaeim urn . . Phone AA Total amount 5 Signature . . (Signature required on credit card and bill-me orders. ) Print heme . ... .. NetZenIou: LLC, DEA GlobaiCompI| nncePaneI " 161 Mission Falls Lane, D 8-" ma/ my company S 7 suite 216. Fremont. CA 94539. USA sum, ” 9,4,, 3 N Phon. ‘1.aoo-“7-s‘a7 (Payment is required by the date 01 the conlerenoe ) T°" '7'. (us): "1‘3°°“7'9‘°7 I F“ (US): “,2 23’ 688‘ Please fill (his form with attendee details and payment details and fax it to 302 233 5334 tii. »-. h,titi. i~i. iit. :.ntenamel | ti'i’i Ai ti(; ilV~'. “ire IE“. -;‘i~. r‘r‘<1 5 «: ;i. iiinit . ».ni; iii; iinevxinei