TUESDAY JULY-1-2014

10:00 AM | 04:00 PM - EDT |DURATION: 360 MINUTES

Live webinar on "6-hr Virtual Seminar: Latin America Understanding Regulatory om!liance Re"uirements Across the Li#e Science $ndustry"
Why Should You Attend: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, iologics and !om"ination Products in #atin America$ The primary countries covered %ill include: Argentina, ra&il and Me'ico$ (ther countries such as!hile, !osta )ica, Dominican )epu"lic, Panama, Peru and *ene&uela %ill "e discussed$ The course %ill cover topics relating to pre+clinical and clinical requirements, as %ell as, addressing the structure of the regulatory agencies in #atin America$ !ontent %ill include descriptions of the methods "y %hich regulators in the corresponding agencies process filings and registrations and %hat is e'pected in the authori&ation and dossier maintenance of licensed products$ The current regulatory climate in #atin America is discussed in detail and several e'amples %ill "e provided to illustrate effective compliance procedures and techniques$ !ommon issues that have caused difficulties for #ife Sciences firms in the region are outlined$ !ourse content %ill e'plain ho% #atin America interacts %ith and utili&es ,!- standards and ho% they relate %ith other national regulatory agencies$ Additionally, participants %ill learn ho% personnel can "est address the conflicts, %hich arise and the "est course for resolution$ We"inar ,ncludes:

Online course manual available for free with your purchase! And remember, youll get a chance to ask your toughest questions during the Q&A session ocation! "our office or conference room #no need to travel!$ %ertificate of Attendance
6 hr virtual seminar Schedule : %&' ( )nline *

&'!''(&&!'' am )resentation &&!'' ( &&!&* +reak &&!&* ( &,!'' noon )resentation &,!'' ( &!'' pm unch &!'' ( &!&' pm Q&A from -orning .ession &!&' ( ,!/* pm )resentation ,!/* ( 0!'' pm +reak 0!'' ( 0!/* pm )resentation 0!/* ( /!'' pm 1inal Q&A

Areas

overed in the Seminar:

Glossar o! T"r#s$ D"!%&%&' ()" O**or(+&%( $ ,o+&(r -a.(s: Ar'"&(%&a/ 0ra1%l/ M"2%.o$ La(%& A#"r%.a3s R"'+la(or S(r+.(+r" !or ()" L%!" S.%"&." Pro4+.( I&4+s(r%"s M"r.os+r - So+()"r& ,o##o& Mar5"($ 0"'%&&%&' Yo+r ,o#*a& I&6ol6"#"&( %& La(%& A#"r%.a: E2a#*l"s o! ,o+&(r R"7+%r"#"&(s$ R"'%s(ra(%o& 8 R"7+%r"4 ,o+&(r L%."&s"s$ ,o##o& -""s )verview o# the Rules +overning ,edicinal -roducts . ,edical &evices S"l".( E2a#*l"s o!:,l%&%.al Tr%als/ G,P/ GMP/ S*".%als/ Mar5"(%&' A+()or%1a(%o&s/ Pro4+.( ,lass%!%.a(%o&s/ S.%"&(%!%. A46%."/ G"&"r%.s Pr%.%&'/ Pa("&(s/ La9"l%&'/ SP,/ :ar%a(%o&s/ Ma&+!a.(+r%&' L%."&s"s/ R"&";als/ P)ar#a.o6%'%la&."/ Or*)a& Dr+'s$ ,ar/eting Authori0ation -rocesses - 1ilings . Registrations Dr+' 6s$ M"4%.al D"6%." 6s$ 0%olo'%. 6s$ ,o#9%&a(%o& Pro4+.( &rug ,aster 1ile (&,1* Use in Latin America Registration Use o# %2!ert Re!orts3 -rocessing Variations on Licensed -roducts :ar%a(%o&s: ,)a&'"s (o Mar5"("4 Pro4+.(s$ T *"s o! :ar%a(%o&s$ Doss%"r Ma%&("&a&." E2*".(a(%o&s$ ,)a&'"s ,o&."r&%&' Ma&+!a.(+r%&' As*".(s <Pro4+.( = Pro."ss>$

Labeling . -ac/aging Lea#let Re"uirements Or*)a& Dr+'s 8 Rar" D%s"as"s

Live
One 4ial 5n ( One 2,33Attendee One 4ial 5n ( 6nlimited attendance #7o be arranged in a 2033%onference room8-eeting room9 :ote ! Only One 4ial 5n Allowed$

om!aring and 1&A

ontrasting Latin American -rocedures vs3 the U3S3

Comparison of Processes. Agency Interactions. Accepted Practices.

4ow and 5hen to $n#luence the Regulatory -rocess

Accepted Country Practices. Effective Monitoring Activity. Association vs. Individual Company Involvement & Intervention.

Combo
%ombo & #One 4ial 5n ( 6nlimited 2/,3attendance ; On 4emand <ecorded .ession$ %ombo , #One 4ial 5n ( 6nlimited 2/33 attendance ; 7raining %4$

'he Regulatory 6egotiation -roces

Effective Approaches. The Do's and Don'ts of Regulatory Involvement.

4ow to Use Regulations 7 Regulatory

Check-in Procedure. Agency Interactions. Business Impact Within and Outside Latin America. Professionalism in Regulatory Lobbying.

ontacts to 8our Advantage

Recorded
On 4emand # 3' 4ays of online 20*3.treaming access available after the live session $ )lay +ack ( 6nlimited =iews # <ecorded file 2033 available for download after the live session $ >et 7raining %4 2/,3

Resources 7 4el!#ul 5ebsites 5ho 5ill 9ene#it:

This course will be beneficial to:

Multiple Location
2&*' -ultiple location ' ( 6p to * 4ial in 2?/3 allowed

Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements QA / QC Personnel Global Supply Chain personnel Clinical / Pharma & Device personnel Manufacturing personnel Global Business Development personnel Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization

A9o+( S*"a5"r
For any assistance contact us at support@compliance2go.com or call us at 877.782.4696 Or Visit us:- )((*s:88.o#*l%a&."2'o$.o#8*ro4+.(8?

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