美食化學製藥技術服務部 高級專員 - 陳秋萍

CONTENTSPart I: 公司簡介Part II: 如何找工作 ?

Part III: 如何寫履歷、面試 ?

Part IV: 職場該注意的事項

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PART I: COMPANY

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MILESTONES

1996 LOTUS Medical Supply acquired Mei-Shih and renamed it Lotus Pharmaceutical Co., Ltd.

2004 Complete CGMP validationAugust

Industrial Sustainable Excellence Award from Ministry of Economic Affairs (MOEA)

November

Awarded Three Medals from Department of Health (DOH)December

2005HRA (France) Toll manufacturing contract

JanuaryPlant Registration Certificate from The Republic of Sudan

Calao (Italy) Joint venture project with LOTUSDecember

2006Biokey company (USA) Toll manufacturing contract Commencement of a new CGMP building EU IMPD Submission

September

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MILESTONES

2007 US IND Submission (Application No.: 71873)November

2008First US ANDA Submission (Application No.: 90-906)September

Licensed Emergency Pill to Bayer TaiwanDecember

2009Product registration in India (Registration No.: FF-516)June

Second US ANDA Submission (First to File) (Application No.: 91-608)July

Licensed Sibutramine Tablet to Bayer TaiwanNovember

Technical transfer partnership with Rhodes Pharmaceutical in US

December

2010 IPO in TaiwanJanuary

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MILESTONES

2010 US FDA Pre-Approval Inspection

CDMO (Contract Development Manufacturing Organization) with Bayer Taiwan

Received Accreditation Certificate of Foreign Drug Manufacturer from Japan PMDA (Registration No.: AG1060007)

Received US FDA Establishment Inspection Report; Classified as Acceptable

February

March

April

Third US ANDA Submission [Project: LTT75], Paragraph IV Challenge (Application No.: 202095)

Received PIC/S Approval from Taiwan TFDA

July

August

Complete Area B extension & Soft gelatin capsules manufacturing area extension

Forth US ANDA Submission [Project: LNT15] (Application No.: 202246)

September

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2010

MILESTONESReceive First ANDA Approval Letter [Project: BK123]

Fifth US ANDA Submission [Project: LTT50] (Application No.: 202722)

November

December

2011Sixth US ANDA Submission [Project: LNT07] (Application No.: 202684)

Seventh US ANDA Submission [Project: CAC] (Application No.: 203298)

CDMO (Contract Development Manufacturing Organization) with Bayer Berlin

January

July

September

First Commercial Shipment to US

First Clinical Supply to Japan

Eighth US ANDA Submission [Project: TMZ] (Application No.: 203722)

November

December

October

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MILESTONES

2012 PIC/S GMP Inspection for soft capsule dosage form

PIC/S GMP Inspection for cytotoxic drug (hard capsule) manufacturing area from Taiwan TFDA

Ninth US ANDA Submission [Project: LP127] (Application No.: 204501)

US FDA Pre-Approval and Compliance Inspection, no 483 deficiency [For general pharmaceutical IR, ER tablet and high potency tablet]

April

May

June

August

10th US ANDA Submission [Project: LP250] (Application No.: 204951)

11th US ANDA Submission [Project: LP251] (Application No.: 204933)

September

First EU Submission [Project: LP250,LP251] (Application No.: NL/H/2855/001-002/DCOctober

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MILESTONES

Receive Certification of GMP of Compliance of Manufacture from EudraGMP system.(Certification No. : NL/H 13/0104)

Receive Certification of PIC/S GMP Regular Inspection from TFDA. [Application No.: (AP)0119015]

February

April

2013

Japan Meiji Contractor Audit

US Alvogen Contractor Audit

Japan Aska Contractor Audit

Receive Registration Certificate of TS-1[ LP620,LP621] from PMDA

Japan Nipro Contractor Audit

May

June

August

US Alvogen Contractor AuditOctober

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MILESTONES

Germany Bayer Contractor Audit

PIC/S GMP Inspection for cytotoxic drug (hard capsule) manufacturing area from Eudra GMP

Receive Certification of GMP of Compliance of Manufacture from EudraGMP system.(Certification No. : NL/H 14/1002296)

May

June

September

2014

Lotus alliance with AlvogenAugust

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PRODUCTION LINE• Production line: non-sterile dosage

– Primarily oral dosage form (tablets and capsules)– Others include: liquid dosage, semi-solid dosage (currently for domestic products only)

• Current Production Area

Production Area Area A Area B Area C Area H

Product Type General High potency Cytotoxic Softgel Capsule

No. of Products More than 50

3 (Apano Tablet,

Ansuzole Tablet, Holly-Anne Tablet)

4(TS-1, Tamos 100mg, Furil, Thali, and several in R&D pipeline)

2Bensau Soft Capsule 200 mg, Zcough Soft

Capsule 100 mg

EquipmentsFor tablets, hard gelatin capsules,

liquid & semi-solidTablets

Equipment capable for production of tablets,

hard gelatin capsules & soft gel capsules

For Softgel Capsule only

* This table is base on Safe Bridge definition, for material above class 3

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LOTUS AS LICENSE HOLDER IN TAIWAN

70LOTUS AS CONTRACT ACCEPTOR FOR

MANUFACTURING IN TAIWAN

4LOTUS AS LICENSE HOLDER FOR CONTRACT

MANUFACTURING IN TAIWAN

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PART II:如何找工作 ?

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讓工作來找我• 增加自己的專業度• 增加語文能力 ( 英文 )

• 把握實習的機會，增加能見度• 勇於嘗試• 第一份工作的熱誠很重要

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• 面試的好印象

• 服裝

• 談吐

• 身體語言

• 如何行銷自己

Part III: 如何寫履歷、面試 ?

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履歷

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面試的好印象• 準時 ( 早到、遲到 )

• 服裝• 談吐• 身體語言• 如何行銷自己

Part VI: 職場該注意的事項

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行銷自己 ( 自己就是一個產品 )

賣相

品質

實用

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THANK YOU